C.R. Bard Jobshttp://crbard.jobs2012-05-22 22:02:25.501714USACovingtonDistribution Supervisor Industry Title /Category: Medical Device/Distribution Job ID: 2011-5281 Career Level: experienced Location/Division: Covington, GA/Bard Global Distribution Center Relocation: No Posted Date: 5/17/2012 Close Date: .. C. R. Bard, Inc. (NYSE: BCR)is a leading multinational developer, manufacturer and marketer of innovative, life-enhancing medical technologies in the fields of vascular, urology, oncology and surgical specialty products, employing over 11,000 people in over 25 countries around the world. Founded more than 100 years ago, we pioneered many devices that are now the cornerstones of modern healthcare. We expect the highest levels of quality, integrity, service, and innovation from our employees – on the job and in the communities in which we work and live. In return, we foster an environment where individuals are treated with fairness and respect, and feel valued, acknowledged and rewarded. Be Your Best at Bard – and ultimately, you can have an impact on the lives of people around the world. Apply for this position * Refer a friend to this job More information about this job: Summary of Position with General Responsibilities: This position directs and coordinates activities of the global distribution center operation including case goods, inventory and bulk shipping both domestically and internationally. Essential Job Functions: * Ensures timely and accurate shipments of TL, LTL, CL, LCL, STS, air and ground shipments. * Effectively utilizes and ensures compliance with Bard’s inventory control and warehouse management system (JDE, HighJump, MFGPRO). * Ensures compliance with all applicable company and government policies (FDA, OSHA); compliance with DOT requirements, customer requirements legal procedures, carrier tariffs and contracts. * Ensures departmental procedures, SOP’s and GMP’s/QSR’s are continuously updated. * Plans work schedules and assign duties to maintain adequate staffing levels, to ensure that activities are performed effectively and respond to fluctuating workloads. * Reviews work throughout the work process and at completion, in order to ensure that it has been performed properly. * Transmits and explains work instructions to employees. * Evaluates employee performance, prepare performance appraisals; prepare and maintain work records and reports that include information such as employee time, and inspection results. * Conducts staff meetings to relay general information or to address specific topics such as safety, quality, policy changes, etc. * Counsels employees in work-related activities, personal growth and career development. * Recommends or initiates personnel actions such as promotions, transfers and disciplinary measures; resolve personnel problems complaints or refer them to higher-level management for resolution. * Must be able to work a flexible shift and weekends as business requires. Basic Qualifications: JOB SKILLS, AND COMPETENCIES: VERBAL AND WRITTEN Ability to read, analyze and interpret technical procedures and governmental regulations. Ability to write reports and business correspondence Expresses information clearly, information is organized in a logical manner; speaks using proper grammar, tone and pace. Practices meaningful two-way communication. MATHEMATICAL SKILLS Performs basic math computations accurately; uses appropriate mathematical formulas and techniques. PROBLEM-SOLVING AND DECISION-MAKING Possesses sufficient inductive and deductive reasoning ability to successfully perform job; critically reviews, analyzes, synthesizes, compares and interprets information and applies this when solving problems. Identifies connections between issues and changes direction when working on multiple projects or issues. BASIC COMPUTER SKILLS Understands and efficiently uses basis computer hardware and software to convey and retrieve information. Additional Desirable Qualifications Skills and Knowledge: Preferred Qualifications: Knowledge of principles and methods for moving goods by air, rail, sea or road. Operational experience in FDA, OSHA, GMP/QSR compliance, CPIM, Logistics or Distribution, Process Excellence, Lean and ISO. Education and/or Experience: Bachelor’s Degree or equivalent work experience Minimum 3- 7 years supervisory experience in a fast-paced environment. Physical Demands: Position spends 40% of time walking and standing. Must be able to lift between 30-50 lbs. May require frequent use of stairs. Work Environment: * This position works on the warehouse floor. * The noise level is moderate to high. * The area is subject to wide temperature swings. It is hot in summer (no AC) and cold in winter (very limited heating).2012-05-17 18:27:39United StatesC. R. BardGeorgiaNoneGACovington, GA28762982http://crbard.jobs/xml/28762982/jobUSACovingtonSr. Project Administrator Industry Title /Category: Sr. Project Administrator Job ID: 2012-5651 Career Level: experienced Location/Division: Covington, GA/ Bard Medical Relocation: No Posted Date: 5/10/2012 Close Date: .. C. R. Bard, Inc. (NYSE: BCR)is a leading multinational developer, manufacturer and marketer of innovative, life-enhancing medical technologies in the fields of vascular, urology, oncology and surgical specialty products, employing over 11,000 people in over 25 countries around the world. Founded more than 100 years ago, we pioneered many devices that are now the cornerstones of modern healthcare. We expect the highest levels of quality, integrity, service, and innovation from our employees – on the job and in the communities in which we work and live. In return, we foster an environment where individuals are treated with fairness and respect, and feel valued, acknowledged and rewarded. Be Your Best at Bard – and ultimately, you can have an impact on the lives of people around the world. Apply for this position * Refer a friend to this job More information about this job: Overview: The Sr. Project Administrator position is located at C. R. Bard Medical Division in Covington, GA. Summary of Position with General Responsibilities: This position is responsible for the development, tracking, management, and updating of the division’s Design Control System and to ensure compliance to the Quality System Regulation concerning Design Control for new product development (NPD). This individual will also play a key role in managing information across the entire R&D project portfolio, including front end idea tracking as well as sustaining engineering projects. Essential Job Functions: * Partner in the development, implementation and ongoing support of a new divisional design control system * Owner and ombudsman for division’s design control system for NPD: * Change and update procedures as required with changes in internal (Bard Corporate) and external (FDA, BSI, etc) environment * Proactively manage information within the design control system to organize design reviews, product releases and other major milestones * Manage assignment of training, including determination of who is to be trained in the system components * Audit & ensure Design History Files meet Code of Federal Regulations for medical devices * Develop and manage R&D procurement process (for POs) * Work with finance department to develop and run system for the R&D department * Maintain budgets for respective accounts , including expenses, accruals, etc. * Partner in development of a front end idea tracking system: * Create and maintain portfolio management system for project idea generation (collecting both internal and external ideas) * Conduct monthly meetings to collect and prioritize ideas and projects within this system * Partner in development of Sustaining Engineering (SE) portfolio system: * Create and maintain portfolio management system for SE projects * Conduct monthly meetings to collect and prioritize ideas and projects within this system * Facilitate the effort of developing and optimizing the commercialization process by a continual review of the Design Control system and other development related procedures. * Organize Design History Files for development programs. * Ensure products are produced in accordance with Corporate and Division product development policies. * Assist project members/leaders in preparing/assembling of (market) release documentation. * Assist project leader in the conduct of Technical Design Reviews Basic Qualifications: • Thorough knowledge and understanding of FDA and ISO medical device development regulations; especially as they pertain to design control and product development. • Ability to teach and educate others of these standards as they pertain to product development and design control. • Knowledge of corporate, division, and standard operating procedures, as they relate to both new product development and sustaining engineering. • Knowledge of project-based product development and ability to work as a project member. • Excellent communication skills (written and verbal) with ability to influence. • Proficient in the use of a personal computer with intermediate level of keyboarding skills and proficiency in Microsoft Word, Microsoft Excel, Microsoft Power Point, Microsoft Project, Microsoft Access. • Strong interpersonal skills required in the areas of verbal and written communications, customer focus, telephone manner, time management, professionalism, coaching, influencing, and team building. • Strong information management skills • Strong listening and assessment skills. • Strong analytical thinking, questioning & problem-solving skills. • Excellent organizational and time management skills. • Ability to build and manage database systems for information handling and communication Education and/or Experience: * Minimum undergraduate degree (BS or BA) and a minimum three years experience in medical device or pharmaceutical industry. * Experience with database management and/or information systems required. * Experience in Product Development is desired. * Experience in Quality Assurance is desired. Physical Demands: Employee may be required to sit, bend, stoop, use keyboard, see, talk, hear, and walk and stand on concrete surface for extended periods. May occasionally lift objects up to 25 lbs. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Work Environment: This individual generally will work in an office environment with moderate noise and traffic.2012-05-10 19:02:53United StatesC. R. BardGeorgiaNoneGACovington, GA28606610http://crbard.jobs/xml/28606610/jobUSACovingtonPurchasing Administrative Assistant Industry Title /Category: Administrative Assistant/Operations Job ID: 2012-5644 Career Level: entry level Location/Division: Covington, Georgia/Bard Medical Relocation: No Posted Date: 5/8/2012 Close Date: .. C. R. Bard, Inc. (NYSE: BCR)is a leading multinational developer, manufacturer and marketer of innovative, life-enhancing medical technologies in the fields of vascular, urology, oncology and surgical specialty products, employing over 11,000 people in over 25 countries around the world. Founded more than 100 years ago, we pioneered many devices that are now the cornerstones of modern healthcare. We expect the highest levels of quality, integrity, service, and innovation from our employees – on the job and in the communities in which we work and live. In return, we foster an environment where individuals are treated with fairness and respect, and feel valued, acknowledged and rewarded. Be Your Best at Bard – and ultimately, you can have an impact on the lives of people around the world. Apply for this position * Refer a friend to this job More information about this job: Overview: The Purchasing Administrative Assistant is located at Bard Medical Division in Covington, Georgia. Summary of Position with General Responsibilities: This position provides administrative support to the Global Sourcing Department. This person will perform various administrative duties requiring proficient computer skills, knowledge of office routine, and an understanding of the organization and procedures related to the Global Sourcing Department and its support of the business. The incumbent must demonstrate the ability to assume responsibility without direct supervision, exercise initiative and judgment and make decisions within the scope of assigned authority. Essential Job Functions: * Purchasing - Input, process, and route for signature Indirect PO requisitions for the Covington facility. Maintain purchasing files in accordance with local procedures. * Processing vendor creation forms. * Maintains annual verification fo SBA subcontracting plan and debarment. * Maintain cold call list to support SBA subcontracting plan. * Create monthly Supplier Management Committee presentations. * Departmental Training Coordinator. * Word Processing - types correspondence, monthly reports, and memoranda. * Organizing, Scheduling, and Planning - Organizes meetings and appointments for management; organizes and maintains departmental filing system and training records; orders supplies; organizes and prioritizes workload. * Budget - assists Global Sourcing Manager in monitoring budget and tracking expenditures, comparing and resolving inaccuracies. Prepares and processes check requests and purchase orders. * Travel - Coordinates all staff travel arrangements for seminars, conferences, meetings, etc. Prepares and processes expense reports. * Distribution - Receives, sorts, and distributes mail daily to managers and staff. * Public and Department Relations - Screens and directs calls; takes messages; relays messages; determines and takes needed action on routine messages. Basic Qualifications: • Proficient in the use of a personal computer with intermediate level of keyboarding skills and proficiency in the use of Outlook, Word, Excel, PowerPoint, and Access. • Strong interpersonal skills required in the areas of verbal and written communications, customer focus, professionalism, coaching, and team building. • Superior organizational skills. • Typing 40-60 wpm with accuracy. • Flexible and adaptable to change. • Able to work independently with minimal supervision. • Positive attitude. Overall accuracy and attention to detail. • Above-average capabilities in verbal and written communication, excellent spelling, grammar, and computation skills. • Knowledge of general office procedures necessary. • Experience supporting multiple managers. Education and/or Experience: * High school diploma or equivalent required, additional education desired. * Two (2) years of secretarial and administrative experience required, including confidential data management. Physical Demands: Employee may be required to sit, bend, stoop, use keyboard, see, talk and hear. May occasionally lift objects of 10 to 25 lbs. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Work Environment: This position works in a anormal office environment. The noise level in the work environment is quiet to moderate.2012-05-08 20:34:55United StatesC. R. BardGeorgiaNoneGACovington, GA28551683http://crbard.jobs/xml/28551683/jobUSACovingtonClinical Risk Specialist - RN Industry Title /Category: Clinical Risk Specialist/Healthcare Job ID: 2012-5637 Career Level: experienced Location/Division: Covington, GA/Bard Medical Relocation: No Posted Date: 5/2/2012 Close Date: .. C. R. Bard, Inc. (NYSE: BCR)is a leading multinational developer, manufacturer and marketer of innovative, life-enhancing medical technologies in the fields of vascular, urology, oncology and surgical specialty products, employing over 11,000 people in over 25 countries around the world. Founded more than 100 years ago, we pioneered many devices that are now the cornerstones of modern healthcare. We expect the highest levels of quality, integrity, service, and innovation from our employees – on the job and in the communities in which we work and live. In return, we foster an environment where individuals are treated with fairness and respect, and feel valued, acknowledged and rewarded. Be Your Best at Bard – and ultimately, you can have an impact on the lives of people around the world. Apply for this position * Refer a friend to this job More information about this job: Overview: The Clinical Risk Specialist, RN is located at Bard Medical Division in Covington, Georgia. Summary of Position with General Responsibilities: The Clinical Risk Specialist will investigate medical device product complaints, perform MDR/adverse event reporting, evaluate clinical use of product, coordinate corrective actions to reduce occurrence/risk, and analyze adverse events/complaint trends. This position will ensure that all product complaints are documented, investigated, and reported in compliance to applicable Quality Systems regulations, ISO 13485 requirements, FDA regulations, and Corporate, Division, and International policies and procedures Essential Job Functions: * Ensures that all complaints are received, documented, investigated, and trended in accordance with all applicable procedures and regulations. * Ensures that the manufacturing sources are notified of all complaints on products they manufactured and that complaint samples, when received, are forwarded to the manufacturing sources in a timely manner. Review and approve investigations performed by the manufacturing site or OEM Supplier. Work with Manufacturing Sites and OEM Suppliers to ensure corrective actions are documented and monitored to completion. * Assess clinical severity of reported events based on product usage and patient outcome. Will be required to communicate directly with medical professionals or patients regarding reported event. * FDA-MDR and MHRA-Vigilance contact for responding to adverse event inquiries. Investigates, documents, and files adverse event reports (both domestic and international) for products marketed by BMD. * Review and approve adverse events decision trees in Trackwise (Domestic and International). * Analyze complaints and adverse events and communicate issues and resolutions to management. Generate monthly Adverse Events and Complaint Trending Reports. * Assist project teams with the development of product risk assessment (DFMEA) and clinical severity assessments for new product launches. Transfer risk assessment, predicted occurrence rating, and appropriate defect coding into Field Assurance to ensure proper trending and reporting of complaints following product launch. * Perform complaint handling training with Bard Sales Representatives to ensure all quality defects and adverse events are being reported consistently and in a timely manner to Field Assurance. Basic Qualifications: • Excellent oral and written communication skills and telephone presence/manner. • Detailed oriented -- committed to accuracy, efficiency, and consistency. • Must be customer focused. • Detailed oriented – committed to accuracy, efficiency, and consistency. • Proficient in the use of a personal computer with intermediate level of keyboarding skills. • Strong interpersonal skills required in the areas of verbal and written communications, customer focus, telephone courtesy, professionalism, and influencing. • Ability to handle multiple tasks in an organized/efficient manner and maintain good composure in stressful situations. • Good proofreading skills and memory retention. • Must be able to comprehend and apply QSR and FDA regulations and follow procedures. • Must be able to work in a team environment. Education and/or Experience: * Bachelor’s degree in Nursing required. Clinical experience a plus. * Experience with MS Office software (Word, Excel, and Access). Experience with complaint handling databases (Trackwise) or medical record databases a plus. Physical Demands: While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee is frequently required to use hands to finger, handle or feel. The employee is occasionally required to stand and reach with hands and arms and lifts and/or moves up to fifteen pounds. Employee is required to meet with other personnel in other areas of the building. Specific vision abilities required by this job include close vision. Work Environment: This position works in a normal office environment. The noise level in the work environment is quiet to moderate. This position also has exposure to laboratoryenvironment, which mayrequire handling of all types of chemicals including those that present health, flammability, and reactivity hazards. Must be trained in blood-borne pathogens and handling bio-hazards materials.2012-05-02 18:59:43United StatesC. R. BardGeorgiaNoneGACovington, GA28333218http://crbard.jobs/xml/28333218/jobUSACovingtonSr. Quality Engineer Industry Title /Category: Sr. Quality Engineer/Quality Assurance Job ID: 2012-5636 Career Level: experienced Location/Division: Covington, GA/Bard Medical Relocation: Yes Posted Date: 5/2/2012 Close Date: .. C. R. Bard, Inc. (NYSE: BCR)is a leading multinational developer, manufacturer and marketer of innovative, life-enhancing medical technologies in the fields of vascular, urology, oncology and surgical specialty products, employing over 11,000 people in over 25 countries around the world. Founded more than 100 years ago, we pioneered many devices that are now the cornerstones of modern healthcare. We expect the highest levels of quality, integrity, service, and innovation from our employees – on the job and in the communities in which we work and live. In return, we foster an environment where individuals are treated with fairness and respect, and feel valued, acknowledged and rewarded. Be Your Best at Bard – and ultimately, you can have an impact on the lives of people around the world. Apply for this position * Refer a friend to this job More information about this job: Overview: The Sr. Quality Engineer position is located in Covington, Georgia at Bard Medical Division. Summary of Position with General Responsibilities: •The purpose of this position is to assist Quality Assurance Management in maintaining a department of qualified, motivated, and respected Quality Engineers. This includes assisting all Quality Engineers with the proper tools and guidance to be successful in performing their work, as well as providing them with a work environment conducive to personal and professional success. Additionally, the Senior Quality Engineer functions as a subject-matter resource for Engineering, Operations, Sterilization and outside suppliers. Essential Job Functions: Represents the Corporation, Division and Quality Department in a professional manner. • Participates on Project Team as Quality Representative. Ensures that principals of Design Control are applied to Product and Process Changes and New Product Development. • Provides Quality Assurance leadership for Project Teams or Quality Department. • Creates, reviews and approves Quality System Documents (CAPA, Audits) • Creates, reviews and approves Product Documents • Creates, reviews, and approves Protocols, Process and Product Validations, Stability Protocols, Software Validation documents • Mentors entry point staff • Provides supervision to technicians and engineers • Assists in the review and interviews of potential candidates. • Creates, reviews and approves documents required for Design History File. • Creates, reviews and approves Risk Assessments such as FMEA, FMECA or FTA. • Analyzes process and product non-conformances and implement comprehensive corrective and preventive action plans. • Performs Internal or Supplier Quality System Audits. • Ensures compliance to Department and Division procedures. • Participates and has membership in trade and/or professional organizations to ensure that state-of-the-art industry standards are communicated into the division in an efficient, timely, and accurate manner. • Performs Complaint review and investigation as required. • Tracks and trends Quality Indicators. • Interfaces with manufacturing facility or other Division Facilities. • Serves as Independent QA Reviewer and Chairperson for Design Reviews. Basic Qualifications: • Ability to perform engineering work of a broad nature with little or no direction from Quality Management. Generally, receives guidance on novel or controversial problems. • Extensive knowledge of medical device regulation, industry or international standard, including management responsibility. Ability to understand Division and Plant Quality Systems and be able to implement systemic changes to enhance product quality and improve business efficiency. Ability to interface with regulatory bodies to present technical information. • Comprehensive knowledge of quality systems and relationship to business. • Has experience in writing process, software, and equipment protocols/validations and has fundamental knowledge of validation principles. • Understands basic applied statistics, statistical sampling plans, and statistical process control and advanced statistical methodologies such as DOE and Taguchi. • Ability to serve in leadership roles on projects or assignments. • Comprehensive understanding of auditing principles and ability to perform as a lead auditor. • Ability to participate and provide leadership on teams and maintain positive work environment with those teams. Understands team functions, leadership techniques and project management methodologies. • Broad knowledge of manufacturing processes. • Excellent communication skills (verbal, written, and presentation). Understands how to present information dependent upon the level of the audience. • Understands Fundamentals of Engineering Principles. • Ability to effectively manage time. • Ability to handle multiple task assignments. • Ability to translate quality requirements into product specifications. • Ability to interpret Regulations, Corporate, Division and Department Procedures. • B.S. in Engineering, Engineering Technology, Science a minimum. • American Society of Quality (ASQ) certification (CQE, CQA, CQM, etc.) • Minimum 4 years of experience with FDA regulated industry including three years on product development programs. Additional Desirable Qualifications Skills and Knowledge: * Highly variable operations performed daily from complex regulatory and engineering decisions to routine administrative functions. Interpretation of regulations (GMP, ISO 13485, EN46001) into standards and procedures as required. The ability to explain these interpretations to Plant, Division, Corporate and representatives of Regulatory bodies is necessary. * As a senior engineer, tasks and responsibility are highly complex and very difficult. Considering a few important facts must make judgment for very complex issues; written rules, precedents and policies are available for guiding decisions, but are not always easily attained. Some facts may be difficult to attain and the relationship between facts difficult to establish. There are often instances where quick judgments must be made that can have significant impact to the Company. Individual is looked upon as a decision-resource person, one of high integrity and decision-making skills. * A great deal of work must be initiated through a detailed knowledge and understanding of the job function, the establishment of plans to attain the end goal. There is a great deal of freedom of action, originality and imaginative drive and critical analysis since there is not strict day-to-day supervision. The success of implementation of quality plans is largely dependent upon the person’s ability to recognize the most efficient, cost-effective approach to attaining the desired goal. In many instances, the person will be required to use creativity and imagination in carrying out the job function. This person will be working in a fast-paced, technically challenging environment where drive is critical to success. * Decisions made by this person could have significant regulatory and financial implications. Furthermore, this person’s decisions could have a significant impact on health care practitioners and the welfare of their patients. Education and/or Experience: * B.S. in Engineering, Engineering Technology, Science a minimum. * American Society of Quality (ASQ) certification (CQE, CQA, CQM, etc.) * Minimum 4 years of experience with FDA regulated industry including three years on product development programs. Physical Demands: Employee may be required to sit, bend, stoop, use keyboard, see, talk and hear. May occasionally lift objects up to 25 lbs. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Work Environment: This position works in a normal office environment. The noise level in the work environment is quiet to moderate. Frequent travel is required. When traveling to clinical sites or hospitals, the work environment will be specific to the area under evaluation.2012-05-02 18:58:42United StatesC. R. BardGeorgiaNoneGACovington, GA28333171http://crbard.jobs/xml/28333171/jobUSACovingtonAssociate Quality Engineering Director Industry Title /Category: Associate Director, Quality Engineering Job ID: 2012-5616 Career Level: management Location/Division: Covington, GA/Bard Medical Relocation: Yes Posted Date: 4/23/2012 Close Date: .. C. R. Bard, Inc. (NYSE: BCR)is a leading multinational developer, manufacturer and marketer of innovative, life-enhancing medical technologies in the fields of vascular, urology, oncology and surgical specialty products, employing over 11,000 people in over 25 countries around the world. Founded more than 100 years ago, we pioneered many devices that are now the cornerstones of modern healthcare. We expect the highest levels of quality, integrity, service, and innovation from our employees – on the job and in the communities in which we work and live. In return, we foster an environment where individuals are treated with fairness and respect, and feel valued, acknowledged and rewarded. Be Your Best at Bard – and ultimately, you can have an impact on the lives of people around the world. Apply for this position * Refer a friend to this job More information about this job: Overview: The Associate Quality Engineering Director is location at C.R. Bard Medical Division in Covington, Georgia. Summary of Position with General Responsibilities: The Associate Quality Engineering Director has the responsibility of leading a directed R&D quality function (GLP, GCP, and/or GMP) to assure compliance and approval of new products as measured by acceptance of all data/studies by the applicable regulatory authorities. The primary objective of this position is to assure quality is designed into new products. This includes direct responsible for effective oversight of regulatory inspections, departmental systems, staff development, and personnel performance maintenance. Essential Job Functions: Define, lead and implement quality engineering in the design and development of products, and in transfer and steady state phases of manufacturing operations. Develop and improve quality systems to facilitate business and quality objectives: o Ensure timely independent quality assessment of systems, reports, internal/external facilities and documents that meet the company standard for quality and format. o Resolution process to ensure the organization is alerted to issues in time to resolve potential adverse affects on the customer, company or business. * • Lead NPD Quality Engineering to support quality system design and implementation for compliance with Bard, government regulations and international standards requirements. * • Support product development by preparing quality and reliability plans, reviewing design plans and approving qualifications and validations. Support licenses and acquisitions by investigating levels of compliance, quality and reliability of potential technologies and/or companies (due diligence). * • Managing project and company risks. * • Oversee the analyses, evaluation, and presentation of information concerning NPD compliance audits associated with GLP, GCP and/or GMP requirements in the Research and Development arena. * • Communicate business related issues or opportunities to next management level. * • Lead in Compliance to Design Control requirements. Basic Qualifications: • Technical writing, budgeting, computer and management skills. • Must have a proven track record in NPD Quality Engineering management including successful product launches. • Knowledge and understanding of Document Control practices. • Extensive knowledge of medical device regulation, industry or international standard, including management responsibility. Ability to understand Division and Plant Quality Systems and be able to implement systemic changes to enhance product quality and improve business efficiency. Ability to interface with regulatory bodies to present technical information. • Comprehensive knowledge of quality systems and relationship to business. • Understands basic applied statistics, statistical sampling plans, and statistical process control and advanced statistical methodologies such as DOE and Taguchi. • Ability to participate and provide leadership on teams and maintain positive work environment with those teams. Understands team functions, leadership techniques and project management methodologies. • Broad knowledge of manufacturing processes. • Excellent communication skills (verbal, written, and presentation). Understands how to present information dependent upon the level of the audience. • Understands Fundamentals of Engineering Principles. • Ability to effectively manage time and handle multiple task assignments.. • Ability to translate quality requirements into product specifications. • Ability to interpret Regulations, Corporate, Division and Department Procedures. Additional Desirable Qualifications Skills and Knowledge: * College level mathematical skills. * Basic applied Statistics, statistical sampling plans, statistical process control, DOE, Taguchi Methodology. * Able to take theoretical mathematics and apply to business problems. Education and/or Experience: * • B.S. in Engineering or other applicable technical field. MS or Advanced degree highly recommended. * • Must have 10 years of Quality System (QSR and ISO 13485:2003) management experience * • Must have at least 8 years experience with Industrial EO Sterilization of medical devices * • Must have 8+ years of managerial/leadership experience * • Working knowledge of ISO, Medical Device Directive, GMP/QSR and other applicable Regulations – ASQC certified engineer required. Physical Demands: The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to sit and talk and hear. The employee is occasionally required to stand, walk, reach with hands and arms and lift and/or move up to 25 pounds. The employee is required to withstand the normal rigors of short and long travel situations and meet with other personnel in various areas of the building. Specific vision abilities required by this job include close vision and distant vision. Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. This position is in an office and/or manufacturing environment.2012-04-23 18:28:39United StatesC. R. BardGeorgiaNoneGACovington, GA28077632http://crbard.jobs/xml/28077632/jobUSACovingtonSr. Tool Maker Industry Title /Category: Sr. Tool Maker Job ID: 2012-5510 Career Level: experienced Location/Division: Covington, GA/ Bard Medical Relocation: No Posted Date: 3/5/2012 Close Date: .. C. R. Bard, Inc. (NYSE: BCR)is a leading multinational developer, manufacturer and marketer of innovative, life-enhancing medical technologies in the fields of vascular, urology, oncology and surgical specialty products, employing over 11,000 people in over 25 countries around the world. Founded more than 100 years ago, we pioneered many devices that are now the cornerstones of modern healthcare. We expect the highest levels of quality, integrity, service, and innovation from our employees – on the job and in the communities in which we work and live. In return, we foster an environment where individuals are treated with fairness and respect, and feel valued, acknowledged and rewarded. Be Your Best at Bard – and ultimately, you can have an impact on the lives of people around the world. Apply for this position * Refer a friend to this job More information about this job: Overview: The Sr. Tool Maker position is located at C.R. Bard Medical Division in Covington, GA. Summary of Position with General Responsibilities: This position is responsible for the development and fabrication of prototypes, models, equipment and fixtures to meet engineering specifications. This position works directly with engineering to identify needs, create specifications and build models. This position is responsible for the maintenance and upkeep of all machine shop equipment, tooling and fixtures. This position contributes directly to the output of the department by supporting shop activities as required to meet customer needs. This position supports the design and development process, along with providing manufacturing support. Essential Job Functions: * Fabricate working prototypes of products and recommend performance enhancements or design changes * Provide concepts for tooling and fixturing required to fabricate and/or characterize device performance * Develop fabrication methods for parts to reduce cost prior to transfer of designs to production * Maintain current knowledge of processing/manufacturing technologies related to the medical device industry * Demonstrate understanding of GD&T * Design and build prototype and short run tooling for plastic injection molding * Demonstrate ability to work to tight tolerances (+/- .0005”) * Demonstrate ability to evaluate prototype components for conformance to design intent via inspection and functional evaluation * Maintain comprehensive and accurate lab notebook/records Basic Qualifications: • Hands on experience in CNC machining, turning and other metalworking fabrication methods • Ability to read and interpret engineering drawings, specifications, and manufacturing documents • Ability to design and build prototypes and test fixtures of significant complexity with efficiency and accuracy • Ability to solve problems and create designs for tooling and fixtures of significant scope and complexity – works under minimal supervision • Proficient with CAD/ CAM software; ability to create CAD models of moderate complexity • Proficient in GD&T • Requires track record of device development success • Proficient in Microsoft Office • Strong listening and assessment skills • Strong questioning & problem-solving skills Education and/or Experience: * 2 year technical degree or equivalent is preferred * 5 – 7 years related experience preferred Physical Demands: While performing the duties of this job, the employee is regularly required to sit, walk, talk or hear. The employee will sometimes be required to move around in manufacturing facility or meet with medical professionals in hospital environment. Specific vision abilities required by this job include close vision and color vision. Some lifting up to 25 lbs. may be required. Work Environment: While performing the duties of this job, the employee regularly works near moving mechanical parts. The employee is occasionally exposed to risk of electrical shock. The noise level in the work environment is usually very loud. Operate and maintain equipment and measurement instruments.2012-04-11 12:36:00United StatesC. R. BardGeorgiaNoneGACovington, GA27814904http://crbard.jobs/xml/27814904/jobUSACovingtonClinical Research Associate Industry Title /Category: Clinical Research Associate Job ID: 2012-5481 Career Level: experienced Location/Division: Covington, GA/ Bard Medical Relocation: No Posted Date: 2/21/2012 Close Date: .. C. R. Bard, Inc. (NYSE: BCR)is a leading multinational developer, manufacturer and marketer of innovative, life-enhancing medical technologies in the fields of vascular, urology, oncology and surgical specialty products, employing over 11,000 people in over 25 countries around the world. Founded more than 100 years ago, we pioneered many devices that are now the cornerstones of modern healthcare. We expect the highest levels of quality, integrity, service, and innovation from our employees – on the job and in the communities in which we work and live. In return, we foster an environment where individuals are treated with fairness and respect, and feel valued, acknowledged and rewarded. Be Your Best at Bard – and ultimately, you can have an impact on the lives of people around the world. Apply for this position * Refer a friend to this job More information about this job: Overview: The Clinical Research Associate position is located at C. R. Bard Medical Division in Covington, GA. Summary of Position with General Responsibilities: The Clinical Research Associate (CRA) supports the day to day operations associated with the execution of clinical trials. He / she will provide support for multiple clinical trial sites and studies. The primary objective and purpose of this position is to ensure the overall quality of clinical trials by supporting the collection of quality study data and managing site adherence to the protocol, GCP, all applicable regulations and related study documents. In conjunction with the Clinical Affairs Department, the CRA is a subject matter expert and acts as a contact for field staff and study site. He / she will participate in site and device training, regulatory document completion, and ensuring case report forms are accurate, complete and verifiable against source documents. The CRA will assume additional site management responsibilities as required. Essential Job Functions: This position includes the following duties and responsibilities. Other duties may be assigned. * Assist clinical team with study start-up activities: * Assist in development of protocol / ICF / CRF / CRF completion guidelines and monitoring plans; * Assist in identification and qualification of clinical study sites; * Site management and study execution activities: * Assist in planning and conducting protocol and device training; * Act as a subject matter expert for field and site staff; * Complete timely and accurate trip reports; * Track and account for study devices; assess and monitor that investigational devices are available, appropriately used, handled correctly, stored, and accurately inventoried and documented; * Follow up with the site regarding timely completion and retrieval of CRFs and data correction forms; * Assist with regulatory documentation at both the investigator site and Bard; * Verify appropriate reporting and documentation of adverse device events, protocol deviations and subject enrollment; * Document and report non-compliance in a timely manner. Identify areas requiring follow-up and improvement at each clinical site, recommend corrective action and or conduct site re-training as needed; * Communicate findings from contact reports and monitoring visits to Clinical / Project Manager in a timely manner. Basic Qualifications: An individual must have experience and be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability necessary. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. • Understanding of basic operational aspects of clinical research and regulatory requirements • Good interpersonal, problem solving and communication skills; • Excellent follow-through capability; • Self-motivated, attention to detail and organizational skill; • Experience with various computer systems / applications; willingness to learn new systems / databases. Education and/or Experience: * BS/ BA or higher in a related scientific area preferred; a minimum of an RN is required * Minimum of 3 years Critical/Intensive Care Unit experience desired Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to sit, walk, talk or hear. The employee will sometimes be required to move around in manufacturing facility or meet with medical professionals in a hospital environment. Specific vision abilities required by this job include close vision and color vision. Employee is required to meet with other personnel in other areas of the building. Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. This position is in an office environment. No special work environment conditions other than minimal exposure to manufacturing environment (i.e. noise, minimal heat and some chemical fume exposure), laboratory, and hospital settings. Travel will be required.2012-02-21 19:16:21United StatesC. R. BardGeorgiaNoneGACovington, GA26650668http://crbard.jobs/xml/26650668/jobUSACovingtonGeneral Accounting Manager Industry Title /Category: General Accounting Manager Job ID: 2012-5398 Career Level: management Location/Division: Covington/BMD Relocation: Yes Posted Date: 1/10/2012 Close Date: .. C. R. Bard, Inc. (NYSE: BCR)is a leading multinational developer, manufacturer and marketer of innovative, life-enhancing medical technologies in the fields of vascular, urology, oncology and surgical specialty products, employing over 11,000 people in over 25 countries around the world. Founded more than 100 years ago, we pioneered many devices that are now the cornerstones of modern healthcare. We expect the highest levels of quality, integrity, service, and innovation from our employees – on the job and in the communities in which we work and live. In return, we foster an environment where individuals are treated with fairness and respect, and feel valued, acknowledged and rewarded. Be Your Best at Bard – and ultimately, you can have an impact on the lives of people around the world. Apply for this position * Refer a friend to this job More information about this job: Overview: This position coordinates all aspects of general accounting, including general ledger, consolidating, reporting, commissions, sales tracing and payroll. Coordinates the efforts between General Accounting and other departments and divisions. This position aids in construction of Sales Force Commission Plan and Financial Analyses on business opportunities. Summary of Position with General Responsibilities: • Oversees the selection, orientation, development, and retention of a sufficient number of qualified staff to carry out the responsibilities of the General Accounting function. • Coordinates annual budget cycles and reviews departmental projections and capital and balance sheet accounts. • Responsible for integrity and accuracy of all reporting. • Reviews month-end financials, investigate areas of question. • Through active communication, remains informed on marketing programs and Research and Development projects and the priority of each. • Maintains good working relationships with all commercial disciplines. • Completion of year-end closing schedules: Annual Report, 10-K, Tax Package. • Actively participates in major project teams. • Administration and Compliance to Corporate and divisional policies and procedures including SOX. • Special assignments as determined by Division Controller. • Manage multiple deliverables under tight deadlines. Basic Qualifications: • Proficient in the use of a personal computer with intermediate level of keyboarding skills, MS Excel, MS Word, MS Access, JDEdwards, Hyperion and PeopleSoft. • Strong interpersonal skills required in the areas of verbal and written communications, customer focus, professionalism, coaching, and team building. • Strong listening and assessment skills • Strong questioning and problem-solving skills • Ability to work in a matrix organization Education and/or Experience: * Bachelor of Accounting degree (B.A./B.S.) from four-year college or university * Seven (7) to ten (10) years experience in general accounting within a manufacturing environment. * Five years supervisory experience is preferred. CMA or CPA is a plus. * Cost Accounting experience is very beneficial. Physical Demands: Employee may be required to sit, bend, stoop, use keyboard, see, talk and hear. May occasionally lift objects up to 25 lbs. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Work Environment: This position works in a normal office environment. The noise level in the work environment is quiet to moderate. Travel 5-10%2012-01-10 18:23:40United StatesC. R. BardGeorgiaNoneGACovington, GA25802967http://crbard.jobs/xml/25802967/jobUSACovingtonSite Strategic Sourcing Manager Industry Title /Category: Sourcing Manager/Purchasing Job ID: 2011-5312 Career Level: experienced Location/Division: Covington, GA/Bard Medical Relocation: No Posted Date: 11/21/2011 Close Date: .. C. R. Bard, Inc. (NYSE: BCR)is a leading multinational developer, manufacturer and marketer of innovative, life-enhancing medical technologies in the fields of vascular, urology, oncology and surgical specialty products, employing over 11,000 people in over 25 countries around the world. Founded more than 100 years ago, we pioneered many devices that are now the cornerstones of modern healthcare. We expect the highest levels of quality, integrity, service, and innovation from our employees – on the job and in the communities in which we work and live. In return, we foster an environment where individuals are treated with fairness and respect, and feel valued, acknowledged and rewarded. Be Your Best at Bard – and ultimately, you can have an impact on the lives of people around the world. Apply for this position * Refer a friend to this job More information about this job: Overview: The Purchasing Supervisor is located at C. R. Bard Medical Division in Covington, Georgia. Summary of Position with General Responsibilities: This position is responsible for: • Coordination and oversight of Bard Medical Division (BMD) Purchasing department personnel. • Responsibility for maintaining effective procurement practices and efficient management of suppliers relating to direct materials, including components, sub-assemblies and OEM finished goods to support the development and commercialization of new products (NPD), line extensions (LE) and sustaining engineering (SE) projects by working closely with internal support teams and external suppliers. Essential Job Functions: Including the following; other duties may be assigned: * Authorized purchasing agent of the company responsible for managing and directing all direct material purchases, including components, sub-assemblies and O.E.M. finished goods, in support of NPD, LE and SE projects. * Responsible for supporting divisional project and manufacturing operations with a steady and uninterrupted flow of raw materials and finished goods by establishing a smooth and consistent flow. * Works directly with external raw material and finished goods suppliers in establishing competitive unit pricing, zero defect product quality and 100% on-time delivery performance. * Works with internal customers and external suppliers in generating tangible cost savings on a regular basis. Initiates, promotes and directs cost improvement / avoidance as a routine responsibility. * Coordinates quarterly review process with key suppliers in which internal team members representing various disciplines such as marketing, planning, quality assurance and engineering meet on a regular basis to discuss quarterly supplier performance, ongoing projects, new award of business opportunities and industry trends. * Negotiates long-term contracts with key suppliers in which favorable terms and conditions are established. * Works with Quality Assurance personnel in monitoring supplier quality issues and maintaining general supplier accountability in the quality arena. * Responsible for the formal supervision, training, development and general guidance of directly reporting purchasing personnel. * Assists in establishing company direction relating to strategic supplier selection via professional recommendations and documented supplier performance records. * Ensures effective training of direct reports and conformance to all SOPs and DOPs. * Facilitates make / buy analyses and decisions. Basic Qualifications: • Proficient in the use of a personal computer with intermediate level of keyboarding skills. • High level of maturity and people skills are essential in successfully interacting with diversified internal and external customer base. • Strong interpersonal skills required in the areas of verbal and written communications, telephone courtesy, professionalism, and influencing. • Strong listening and assessment skills. • Strong questioning & problem-solving skills. • Must possess high degree of proficiency in negotiating commodity unit pricing as well as other general business terms and conditions associated with short and long-term contracts. Requirements also include high degree of professional aggressiveness and initiative in reducing raw material costs. Education and/or Experience: * Four-year degree is mandatory, preferably in a related field such as planning and/or purchasing management. * Three (3) to five (5) years of professional purchasing experience within a high volume, dynamic manufacturing environment is highly desirable. Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. While performing the duties of this job, the employee is regularly required to sit, use hands to finger, handle or feel, reach with hands and arms, talk and hear. The employee is occasionally required to climb or balance and stoop, kneel, crouch or crawl. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this position include close vision and distance vision. Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of the position. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. The position is in an indoor office setting. The noise level in the work environment is usually quiet.2011-11-21 22:32:58United StatesC. R. BardGeorgiaNoneGACovington, GA24990908http://crbard.jobs/xml/24990908/jobUSACovingtonQuality Systems Manager Industry Title /Category: Quality Systems Manager/Quality Assurance Job ID: 2011-5261 Career Level: management Location/Division: Covington, GA/Bard Medical Relocation: Yes Posted Date: 10/28/2011 Close Date: .. C. R. Bard, Inc. (NYSE: BCR)is a leading multinational developer, manufacturer and marketer of innovative, life-enhancing medical technologies in the fields of vascular, urology, oncology and surgical specialty products, employing over 11,000 people in over 25 countries around the world. Founded more than 100 years ago, we pioneered many devices that are now the cornerstones of modern healthcare. We expect the highest levels of quality, integrity, service, and innovation from our employees – on the job and in the communities in which we work and live. In return, we foster an environment where individuals are treated with fairness and respect, and feel valued, acknowledged and rewarded. Be Your Best at Bard – and ultimately, you can have an impact on the lives of people around the world. Apply for this position * Refer a friend to this job More information about this job: Overview: The Quality Systems Manager is located in Covington, GA at Bard Medical Division. Summary of Position with General Responsibilities: The purpose of this position is to maintain a department of qualified, motivated, and respected Quality Engineers. This includes assisting all Quality Engineers with the proper tools and guidance to be successful in performing their work, as well as providing them with a work environment conducive to personal and professional success. Additionally, the Quality Systems Manager functions as a subject-matter resource for Engineering, Operations, Sterilization and outside suppliers. Essential Job Functions: * Represents the Corporation, Division and Quality Department in a professional manner. * Participates on Project Team as Quality Representative. Ensures that principals of Design Control are applied to Product and Process Changes and New Product Development. * Provides Quality Assurance leadership for Project Teams or Quality Department. * Creates, reviews and approves Quality System Documents * Creates, reviews and approves Product Documents * Creates, reviews, and approves Protocols, Process and Product Validations, Stability Protocols * Mentors entry point staff * Provides supervision to technicians and engineers * Assists in the review and interviews of potential candidates. * Creates, reviews and approves documents required for Design History File. * Creates, reviews and approves Risk Assessments such as FMEA, FMECA or FTA. * Analyzes process and product non-conformances and implement comprehensive corrective and preventive action plans. * Performs Internal or Supplier Quality System Audits. * Ensures compliance to Department and Division procedures. * Participates and has membership in trade and/or professional organizations to ensure that state-of-the-art industry standards are communicated into the division in an efficient, timely, and accurate manner. * Performs Complaint review and investigation as required. * Tracks and trends of Quality Indicators. * Interfaces with manufacturing facility or other Division Facilities. * Serves as Independent QA Reviewer and Chairperson for Design Reviews. Basic Qualifications: • Ability to perform engineering work of a broad nature with little or no direction from Quality Management. Generally, receives guidance on novel or controversial problems. • Extensive knowledge of medical device regulation, industry or international standard, including management responsibility. Ability to understand Division and Plant Quality Systems and be able to implement systemic changes to enhance product quality and improve business efficiency. Ability to interface with regulatory bodies to present technical information. • Comprehensive knowledge of quality systems and relationship to business. • Has experience in writing protocols/validations and has fundamental knowledge of validation principles. • Understands basic applied statistics, statistical sampling plans, and statistical process control and advanced statistical methodologies such as DOE and Taguchi. • Ability to serve in leadership roles on projects or assignments. • Comprehensive understanding of auditing principles and ability to perform as a lead auditor. • Ability to participate and provide leadership on teams and maintain positive work environment with those teams. Understands team functions, leadership techniques and project management methodologies. • Broad knowledge of manufacturing processes. • Excellent communication skills (verbal, written, and presentation). Understands how to present information dependent upon the level of the audience. • Understands Fundamentals of Engineering Principles. • Ability to effectively manage time. • Ability to handle multiple task assignments. • Ability to translate quality requirements into product specifications. • Ability to interpret Regulations, Corporate, Division and Department Procedures. Additional Desirable Qualifications Skills and Knowledge: * Highly variable operations performed daily from complex regulatory and engineering decisions to routine administrative functions. Interpretation of regulations (GMP, ISO 9000, EN46001) into standards and procedures as required. The ability to explain these interpretations to Plant, Division, Corporate and representatives of Regulatory bodies is necessary. * As a senior engineer, tasks and responsibility are highly complex and very difficult. Considering a few important facts must make judgment for very complex issues; written rules, precedents and policies are available for guiding decisions, but are not always easily attained. Some facts may be difficult to attain and the relationship between facts difficult to establish. There are often instances where quick judgments must be made that can have significant impact to the Company. Individual is looked upon as a decision-resource person, one of high integrity and decision-making skills. * A great deal of work must be initiated through a detailed knowledge and understanding of the job function, the establishment of plans to attain the end goal. There is a great deal of freedom of action, originality and imaginative drive and critical analysis since there is not strict day-to-day supervision. The success of implementation of quality plans is largely dependent upon the person’s ability to recognize the most efficient, cost-effective approach to attaining the desired goal. In many instances, the person will be required to use creativity and imagination in carrying out the job function. This person will be working in a fast-paced, technically challenging environment where drive is critical to success. * Decisions made by this person could have significant regulatory and financial implications. Furthermore, this person’s decisions could have a significant impact on health care practitioners and the welfare of their patients. Education and/or Experience: * B.S. in Engineering, Engineering Technology, Science a minimum. * American Society of Quality (ASQ) certification (CQE, CQA, CQM, etc.) * Minimum 8 years of experience with FDA regulated industry including three years on product development programs. Physical Demands: Employee may be required to sit, bend, stoop, use keyboard, see, talk and hear. May occasionally lift objects up to 25 lbs. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Work Environment: ??Normal office environment - noise level is quiet to moderate - frequent travel is required - when traveling to clinical sites or hospitals, work environment will be specific to the area under evaluation.2011-10-28 18:13:43United StatesC. R. BardGeorgiaNoneGACovington, GA24471338http://crbard.jobs/xml/24471338/jobUSACovingtonField Assurance Manager Industry Title /Category: Field Assurance Manager/Quality Assurance Job ID: 2011-5260 Career Level: management Location/Division: Covington, GA/Bard Medical Relocation: No Posted Date: 10/28/2011 Close Date: .. C. R. Bard, Inc. (NYSE: BCR)is a leading multinational developer, manufacturer and marketer of innovative, life-enhancing medical technologies in the fields of vascular, urology, oncology and surgical specialty products, employing over 11,000 people in over 25 countries around the world. Founded more than 100 years ago, we pioneered many devices that are now the cornerstones of modern healthcare. We expect the highest levels of quality, integrity, service, and innovation from our employees – on the job and in the communities in which we work and live. In return, we foster an environment where individuals are treated with fairness and respect, and feel valued, acknowledged and rewarded. Be Your Best at Bard – and ultimately, you can have an impact on the lives of people around the world. Apply for this position * Refer a friend to this job More information about this job: Overview: The Field Assurance Manager position is located at Bard Medical Division in Covington, Georgia. Summary of Position with General Responsibilities: This position manages the Field Assurance Department from a global perspective and provides a high degree of confidence that all product complaints received on products manufactured and/or marketed by Bard Medical Division and Bard Urological Division (BMD and BUD) and any of its business groups are documented and maintained in compliance to applicable Quality Systems regulations, ISO requirements, FDA regulations, and Corporate and Division policies and procedures. Essential Job Functions: * Ensures the accuracy and efficiency of complaint documentation from the initial receipt of a product complaint and opening of a complaint file to the closure of the file. * Maintains customer goodwill through efficient and effective communications and follow-up on customer concerns. * Ensures the selection, orientation, development, and retention of a sufficient number of qualified staff to carry out the responsibilities of the department. * FDA-MDR contact for responding to FDA inquiries and for documentation and reporting of adverse events (both domestic and international) for products marketed by BMD/BUD divisions. * Ensures that all complaints on products marketed by BMD and BUD and any of its associated business groups are received, documented, analyzed, and trended in accordance to Corporate and Divisional policies and procedures, and applicable regulations. * Coordinates the review, investigation, and corrective actions of product complaints with manufacturing source Quality Assurance personnel to ensure consistency and attention to detail in performing and documenting complaint evaluations. * Ensures that upper management is informed of potential recall situations and complaint trends. * Interacts with other manufacturers to establish complaint handling, adverse event reporting, and distributor reporting responsibilities. * Interprets corporate policies and regulations as to how they relate to Field Assurance, and prepare and implement Divisional procedures for conformance. * Manages and conducts product recalls per applicable procedures. * Prepares departmental budget and operates within the budget. * Provides support to project teams in preparing FMEAs, establishing complaint handling, MDR reporting and servicing responsibilities via contracts, reviewing labeling and complaint history on similar products, and monitoring market tests. * Functions as Product Litigation Coordinator and interacts with Corporate Legal in responding to litigation requests, reimbursement requests, and evaluation results requests for BMD/BUD. * Interacts with international facilities with reporting responsibilities to BMD/BUD in establishing standardization of complaint handling and MDR/vigilance compliance. * Develops and implements department DOPs and SOPs. Basic Qualifications: • Proficient in the use of a personal computer with intermediate level of keyboarding skills. • Strong interpersonal skills required in the areas of verbal and written communications, customer focus, service to internal customers, telephone manner, professionalism, coaching, influencing, and team building. • Strong listening and assessment skills. • Strong questioning & problem-solving skills. • Detail oriented, committed to accuracy, efficiency, and consistency. • Good proofreading skills and memory retention. • Must be self-motivated and self-disciplined and able to prioritize and handle multiple tasks and responsibilities. • Must be able to manage people and control stressful situations. • Must be able to maintain a calm and positive approach to negative issues and resolve day-to-day problems associated with managing the personnel and duties of the Field Assurance Department. • Must be able to maintain legible, accurate records. Education and/or Experience: * Four-year degree in science or technical field. * Minimum five to eight years supervisory experience. * Must possess a professional image and demonstrate work maturity. * Minimum eight years experience in Quality Assurance or Regulatory Affairs in a medical device environment. * Must be self-motivated and self-disciplined and able to prioritize and handle multiple tasks and responsibilities. * Must be able to manage people and control stressful situations. Physical Demands: While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee is frequently required to use hands to finger, handle or feel. The employee is occasionally required to stand and reach with hands and arms and lifts and/or moves up to ten pounds. Employee is required to meet with other personnel in other areas of building. Specific vision abilities required by this job include close vision. Work Environment: This position works in a normal office environment. The noise level in the work environment is quiet to moderate. This position also has exposure to laboratory environment, which may require handling of all types of chemicals including those that present health, flammability, and reactivity hazards. Must be trained in blood-borne pathogens and handling bio-hazardous materials.2011-10-28 18:13:42United StatesC. R. BardGeorgiaNoneGACovington, GA24471337http://crbard.jobs/xml/24471337/job