C.R. Bard Jobshttp://crbard.jobs2012-05-23 11:20:47.461265USAWarwickPrincipal Packaging Engineer Industry Title /Category: Medical Device / Packaging Engineering Job ID: 2012-5645 Career Level: experienced Location/Division: Warwick, RI / Davol 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: Principal Packaging Engineer Davol Inc. Warwick, RI Plan, organize and coordinate all Packaging Engineering and labeling related activities including project leadership and management to support development and commercialization of new products; line extensions; manufacturing maintenance of business activities; Cost Improvement Programs; testing and labeling activities to support ever-changing regulatory and industry requirements and investigation, evaluation, and implementation of new packaging concepts, materials and systems. Summary of Position with General Responsibilities: 1.Provide cross-franchise support for new product development and line extension activities including: •Concept development •Project Plans/Schedules •Design reviews and design for manufacturability •Development of prototype packaging 2.Plan and coordinate all packaging related activities to launch and commercialize new products and line extensions including: •Concept and development of packaging methods and processes •Coordination of all new tooling and equipment •Coordination and support of all new vendor tooling and artwork •Development and release of all new product and process documentation •Generation of packaging specifications and associated documentation •Development of packaging test plans •Planning, ordering and coordination of all new component inventory •Qualification and validation of all new equipment, processes and operations •New product cost estimates for packaging •Preparation of AFE(s) •Evaluation and recommendation of new materials •Performance of due diligence activities to support business development initiatives 3.Plan and coordinate all packaging engineering activities to transfer new products and line extensions to manufacturing including: •Development and management of packaging requirements to support the transfer plan •Development and release of all packaging documentation •Generation of all relevant test protocols and technical reports 4.Provide packaging engineering support to manufacturing including the following: •Assessment and development of action plans to overcome packaging related manufacturing and quality issues •Support of cost improvement programs and manufacturing improvement plans related to product packaging 5. Provide leadership for : •Project teams requiring extensive packaging material/component/process activity •Mentoring and developing junior level department personnel Basic Qualifications: •B.S. degree in Packaging Engineering/Packaging Science or related discipline with a minimum of 8 years in packaging engineering & design or MS degree in Packaging Science or related discipline with a minimum of 6 years experience. •Experience as a Project Manager and/or experience supervising direct reports. •Ability to manage a variety of assignments at the same time. •High level of written and verbal communications skills. •Ability to conceptualize ideas, motivate and focus individuals and teams, and drive projects through to completion on time and on budget. •Broad knowledge of properties for materials utilized in primary and secondary packaging, plus packaging methods and equipment. •Strong knowledge of package test methods, process validation, bar coding, and international standards. •Ability to travel occasionally. Additional Desirable Qualifications Skills and Knowledge: * Experience in the medical device or pharmaceutical industries strongly preferred. * Knowledge of FDA and functional requirements for sterile, non-sterile, disposable and reusable devices.2012-05-08 20:34:28United StatesC. R. BardRhode IslandNoneRIWarwick, RI28551674http://crbard.jobs/xml/28551674/jobUSAWarwickSr. Manager, Regulatory Affairs Industry Title /Category: Medical Device / Regulatory Affairs Job ID: 2012-5632 Career Level: management Location/Division: Warwick, RI / Davol Inc. 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: Sr. Manager, Regulatory Affairs Davol Inc. Warwick, RI Summary of Position with General Responsibilities: •Recruit, manage, develop and mentor regulatory professionals, manage budgets and tactics. •Provide strategic global regulatory guidance to complex product lifecycle planning. •Assist in regulatory due diligence and acquisition transfer activities. •Through regulatory professional staff provide strategic input and technical guidance on regulatory requirements to product development teams for successful on-time submissions and clearances/approvals. •Manage and execute pre-approval compliance activities. •Assess the acceptability of quality, preclinical and clinical components for submission filing. •Monitor impact of changing regulations on submission strategies and update internal stakeholders. •Monitor and submit applicable reports and responses to regulatory authorities. •Maintain annual licenses, registrations, listings and patent information. •Ensure compliance with product post-marketing approval requirements. •Review and approve labeling and promotion materials to comply with regulations and company policy. •Provide regulatory support and appropriate follow-up to inspections and audits (eg. FDA, Notified Body). •Develop, implement and manage appropriate regulatory procedures and systems. •Submit/review change controls to determine the impact of change and consequent submission requirements. •Provide regulatory input for product field action. •Provide training for stakeholders on current and new regulatory requirements to ensure compliance. •Conduct pre- IDE meetings with FDA and government agencies. •Function as authorized delegate for function head when required. •Represent Davol/Bard in professional associations, industry/trade groups (local/regional/international) and appropriate standards organizations. Basic Qualifications: •B.S. Science, Engineering, or other medical or technical Degree or experience. Advanced regulatory affairs training required – MS, RAC, or other professional certification. •Additional education highly preferred- MPH, MBA, MS, MA, PhD. •Broad knowledge of materials and manufacturing processes, particularly concerning resorbable technologies, HTCP, biologics, pharmaceuticals. •Knowledge of and experience (8-10 years) with regulatory submission for medical devices (IDE’s, 510(k)’s, PMA’s, outside-US regions). Familiarity with combination products highly preferred. •Must have demonstrated extensive working knowledge with the requirements for medical device registration/licensing in the EU, (Medical Device Directive), Japan, Canada, Australia, Latin America and Asia/Pacific. •Working experience in medical products design and manufacturing quality system principles and practices. •Ability to work independently with confidence, resolve conflicts, and negotiate with a win-win” approach. •Ability to work in a matrix/team environment with prior significant experience supervising and developing regulatory affairs professionals. •Solid skill in written and oral communications. Positive energy and enthusiasm to work in a multi-task environment. Education and/or Experience:2012-05-02 18:59:43United StatesC. R. BardRhode IslandNoneRIWarwick, RI28333219http://crbard.jobs/xml/28333219/jobUSAWarwickSr. Quality Systems Engineer Industry Title /Category: Medical Device / Quality Systems Job ID: 2012-5626 Career Level: experienced Location/Division: Warwick, RI / Davol Inc. Relocation: No Posted Date: 4/26/2012 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: Sr. Quality Systems Engineer Davol Inc. Warwick, RI This position of Sr. Quality Systems Engineer reports to the Supplier Quality Engineering Manager and collaborates with Davol personnel to implement requirements of Davol’s Quality Management System. This includes creation of appropriate systems and documentation associated with internal and external audits, training/education programs, quality system metrics and opportunities for quality system improvements. Scope includes all activities within the Davol Quality Management System. Summary of Position with General Responsibilities: •Administer Internal Audit program to maintain compliance and ISO/EN certification and identify opportunities for improvement throughout the organization. Assist in representing Davol to ISO auditors regarding Quality System issues. •Manage both Internal and External audits tracking progress in an audit software program; adequately document, track and efficiently close audits. Ensure proper DMAIC tools are used for corrective actions. •Coordinate activities with Davol and its manufacturing sites in order to collect metrics related data on monthly/quarterly basis and provide monthly tracking metrics to the Quality Management Team. •Assemble, analyze and report appropriate company metrics and the Total Quality System as part of Quarterly Management Reviews and monthly Quality and Operations RGL Reports. Routinely review the Total Quality System and Policies for adequacy and effectiveness with regards to business objectives and revise as necessary. •Analyze processes identified as needing improvement and assist with identifying and implementing appropriate corrective or preventive actions. Assist in Failure Investigations to assure root cause is identified and verify effectiveness of corrective and preventive actions. Identify "Best Practices" from both internal and external sources and communicate them for incorporation throughout the organization. Perform "Gap Analysis" on current activities to identify goals for improvement. •Manage internal auditor credentialing and documentation. Basic Qualifications: •Bachelor of Science Degree in Engineering, Life Science or other technical discipline with emphasis in Quality Management and Statistics. •Adequate training and experience (4-10 Yrs.) in developing, managing and auditing ISO 13485 quality systems. ASQ Certification CMQ/OE & CQA preferred. •An understanding of statistical techniques and a preference for six sigma GB or BB; working knowledge and experience with DMAIC tools. •Strong working knowledge of Regulatory Requirements (QSR, ISO, MDD). •Ability to communicate and work effectively across departmental/facility lines.2012-04-26 20:51:01United StatesC. R. BardRhode IslandNoneRIWarwick, RI28212372http://crbard.jobs/xml/28212372/jobUSAWarwickRegulatory Affairs Specialist Industry Title /Category: Medical Device/Regulatory/Clinical Affairs Job ID: 2012-5625 Career Level: experienced Location/Division: Warwick, RI/Davol Relocation: No Posted Date: 4/26/2012 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: Regulatory Affairs Specialist Davol Inc. Warwick, RI The position of Regulatory Affairs Specialist will be responsible to provide technical and administrative regulatory support to ensure timely introduction of new products subject to medical products regulations as well as provide regulatory support to marketed products. Summary of Position with General Responsibilities: •Prepare and submit applications to the FDA for clinical testing and marketing of new/modified medical devices (e.g., 510(k)’s, IDE’s, PMA’s). •Assist in determination of the appropriate regulatory submission requirements and strategies for new or modified products. Prepare required documentation as needed (e.g., No 510(k) Rationales). •Coordinate review of FDA submissions and test protocols with Corporate Regulatory, Medical and Legal Departments, and respond to any questions posed by these departments or the FDA. •Prepare applications for international marketing approvals (i.e. CE Mark Technical files and Dossiers, JSTD). •Assist Product Development and Quality Assurance in planning pre-clinical studies and bench testing that will ultimately be used in regulatory submissions. •Assist in the review of proposals for clinical design validations, clinical field trials and customer preference tests. •Represent regulatory affairs on product development teams to provide direction with respect to regulatory/clinical requirements and strategy. •Assist in development of new product instructions for use/promotional material. Review product labeling for compliance with medical device regulations and Division/Corporate Policies. •Provide marketed product regulatory support for change management activities, product registrations, and business improvement activities. Basic Qualifications: - B.S. degree or equivalent with emphasis on Life Sciences. Professional certifications preferred. - Knowledge and experience 1-5 years with regulatory requirements for medical devices including submission of IDE’s, PMA’s and 510(k)’s, and CE mark technical files. Additional Desirable Qualifications Skills and Knowledge: * Good oral and written communications skills and ability to work on cross-functional teams. * Working knowledge of statistics and electronic documentation and information systems. * Ability and desire to travel as needed.2012-04-26 20:50:54United StatesC. R. BardRhode IslandNoneRIWarwick, RI28212368http://crbard.jobs/xml/28212368/jobUSAWarwickSupplier Quality Engineer Industry Title /Category: Medical Device /Engineering Job ID: 2012-5618 Career Level: experienced Location/Division: Warwick, RI / Davol Relocation: no Posted Date: 4/24/2012 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: Supplier Quality Engineer Davol Inc. Warwick, RI This position reports to the Supplier Quality Assurance Manager and is responsible for working with assigned suppliers to implement the requirements of the Davol supplier quality management program. Summary of Position with General Responsibilities: •Auditing, monitoring, evaluating, reporting and improving supplier quality system performance and providing technical support to suppliers as determined by Davol management. •As required, coordinating component and product quality testing for purposes of supplier and component qualification and improvement. •As requested and approved, coordinating with other Bard Divisions to perform quality assessments on common suppliers to minimize costs to Bard/Davol and burden on the suppliers. •Supporting Davol manufacturing sites as requested and approved in the assessments of their respective supplier quality systems for those suppliers designated within the scope of their supplier quality management responsibilities. •Working closely with the Davol Purchasing Department in managing Davol’s Supplier Base. •Identifying and appropriately implementing statistical engineering tools and techniques to evaluate and implement supplier process capability and technical performance. •Evaluating supplier quality systems and strategies compliant with regulatory requirements. •Collecting and analyzing Quality data relating to Supplier Quality. Identifying and defining correction action required, initial corrective action with responsible function and follow-up to assure completion and effectiveness. •Communicating potential for changing supplier quality risk to Davol management. •Providing supplier quality engineering management to support new product design projects as required. •25-50% travel required as determined by business need. Basic Qualifications: • Bachelor’s Degree required in Engineering or other technical discipline required. • Minimum of 2 to 5 years experience in a supplier quality/supplier auditing capacity or equivalent preferred or equivalent quality function. • Demonstrated ability to apply statistical quality engineering tools in a supplier environment. • Preferred working knowledge of medical device manufacturing systems and FDA regulations. • Effective communication and conflict resolution skills. • Effective problem solving techniques. Additional Desirable Qualifications Skills and Knowledge: • ASQ-CQE, CQA preferred • Six Sigma Black Belt/Lean Manufacturing experience preferred.2012-04-24 18:49:08United StatesC. R. BardRhode IslandNoneRIWarwick, RI28144069http://crbard.jobs/xml/28144069/jobUSAWarwickAssociate Product Manager/Product Manager Industry Title /Category: Medical Device / Marketing Job ID: 2012-5564 Career Level: experienced Location/Division: Warwick, RI / Davol Relocation: no Posted Date: 4/4/2012 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: Associate Product Manager / Sr. Product Manager Davol Inc. Warwick, RI Support the Franchise team objectives by leading and executing product management responsibilities with regard to product, programs, policies and processes. Summary of Position with General Responsibilities: •Manage post-market surveillance (PMS) process for assigned product areas •Train new and existing sales personnel on market segment, products and competition. •Develop creative sales tools for project promotion. •Understand the marketplace to develop educated forecasts and budget plans accordingly. •Develop Sales Forecast for respective product line responsibility. •Develop Expense Budget for respective product line responsibility. •Development of sales tools to promote new business and defend existing business. •Participate as marketing member on Product Development Teams. •Make marketing contributions on diverse project teams. •Implement new programs to help drive sales relevant to product line responsibilities. •Manage product inventory with production planning. •Build customer relationships with field sales force and surgeons. •Speak to surgeons and clinicians on a one-on-one basis at conventions and meetings. •Research and utilize direct-to-consumer promotion tactics. •Respond to product inquiries from field sales force. •Manage varying workload based on projects. •Ability to refocus tasks depending on changes in the market. •Develop and execute marketing strategies and tactics. Basic Qualifications: •Bachelor's Degree. •For Associate Product Manager: Minimum of one (1) to three (3) years marketing experience in Medical Device or combination Drug / Device with a Bachelor’s Degree or zero (0) to two (2) years marketing experience (in medical, clinical or technical related field) with an MBA. •For Product Manager: Minimum of three (3) years marketing experience in Medical Device or combination Drug/Device with a Bachelor’s Degree or two (2) years marketing experience (in medical, clinical or technical related field) with an MBA. •Prior experience in healthcare communications, education and promotions. •Excellent written and oral communication skills. •Demonstrates leadership capabilities. •Solid analytical ability and business acumen. •Ability to travel domestically and internationally. Additional Desirable Qualifications Skills and Knowledge: * MBA preferred * Minimum of one year sales experience preferred2012-04-11 12:37:17United StatesC. R. BardRhode IslandNoneRIWarwick, RI27814986http://crbard.jobs/xml/27814986/jobUSAWarwickPrincipal Engineer Industry Title /Category: Medical Device / Engineering Job ID: 2012-5581 Career Level: experienced Location/Division: Warwick, RI / Davol Inc. Relocation: No Posted Date: 4/10/2012 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: Principal Engineer Davol Inc. Warwick, RI Lead product development activities of implantable medical devices from concept through product commercialization. Establish and foster relationships with clinicians and KOL’s. Summary of Position with General Responsibilities: •Technical Lead for development teams from idea generation through product launch •Partner with Marketing to identify unmet customer needs and translate them into product specifications •Develop new product concepts that meet global customer needs •Coordinate design and development activities to ensure project milestones are achieved •Develop testing protocols, DOE’s and summary reports in support of new product development activities. •Lead FMEA and design verification/validation activities •Coordinate prototype fabrication and testing •Develop project timelines and budgets and track progress •Develop intellectual property (IP) •Work closely with cross functional team members to ensure project commitments are achieved •Work closely with manufacturing to meet project milestones •Manage external development partners •Present project updates to Sr. Management Team Basic Qualifications: •BS in Engineering, •Minimum of 8 years experience in product development in the surgical, disposable products or related industries with a Bachelor’s Degree or minimum of 6 years experience in product development in the surgical, disposable products or related industries with a Master’s Degree. •Experience interfacing and building relationships with Clinicians and KOL’s •Familiar with Concept Engineering (i.e., VOC, observational research, ODI, etc..) •Proven track records of developing products from concept to launch •Knowledge of cGMP’s and FDA/CE Mark regulatory requirements •Experience with Design for Six Sigma (DFSS) tools and methodology •Excellent verbal and written communication skills •Track record of managing projects and budgets •Ability to work independently (self directed) •Ability to travel occasionally Additional Desirable Qualifications Skills and Knowledge: * Master’s Degree preferred.2012-04-11 12:37:01United StatesC. R. BardRhode IslandNoneRIWarwick, RI27814967http://crbard.jobs/xml/27814967/jobUSAWarwickAdvanced Quality Engineer/Sr. Advanced Quality Engineer Industry Title /Category: Medical Device Job ID: 2012-5580 Career Level: experienced Location/Division: Davol / Warwick, RI Relocation: Yes Posted Date: 4/10/2012 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: Advanced Quality Engineer / Sr. Advanced Quality Engineer Davol Inc. Warwick, RI The position of the Advanced Quality Engineer/Sr. Advanced Quality Engineer is responsible to assure that new product designs and the processes for manufacturing them meet all Corporate and Divisional requirements with respect to safety and efficacy. This individual will represent quality interests and concerns on project teams and report to the Manager of Advanced Quality Engineering. Summary of Position with General Responsibilities: *Provide technical guidance to Quality Engineers, Quality Technicians, and Inspectors as required based on level. *Lead or Support Quality Engineering Projects to improve Quality Systems and Procedures. *Development of Test Protocols and Final Reports to support Regulatory 510K or PMA submissions. *Development of Risk Management Documents, including the DFMEA, while coordinating input from the other Design Sub-team members. *Development of the Design Verification Protocol and Design Verification Report. *Provide input into the product Design Inputs, Design Outputs, Product Specifications, Product Development Plans, and applicable design control documents as defined per Davol’s product development process. *Support front end product innovation process activities to support new technology integration and transfer to new product development teams. *Determine the degree of Biocompatibility testing required as per ISO10993 requirements. *Develop test protocols and release a final report on Shelf Life Studies in support of expiration dating. Lead Supplier part qualification activities. *Perform test method validations to ensure accuracy, precision, selectivity, sensitivity, stability, and reproducibility of test methods used to assess the safety and efficacy of devices. Basic Qualifications: •Bachelor or Masters Degree in Engineering or Technical Sciences or equivalent combination of Bachelors Degree and related work experience. •AQE (2-5) year’s minimum experience, Senior AQE (5-8) year’s minimum experience in Quality Engineering discipline including design controls, product/process validation, supplier management, and technical problem solving. •An appropriate level of competence in Quality Technology including statistical techniques and six sigma tools including sampling plans, process capability analysis, gage R&R, hypothesis testing, analysis of variance, regression, and design of experiments. •Applied knowledge of the requirements of FDA QSR’s and ISO Quality Systems. Additional Desirable Qualifications Skills and Knowledge: * CQE certificate from American Society for Quality a plus. * Ability to work with and motivate people. * Good oral and written communication skills.2012-04-11 12:36:50United StatesC. R. BardRhode IslandNoneRIWarwick, RI27814960http://crbard.jobs/xml/27814960/jobUSAWarwickAdvanced Quality Engineer Industry Title /Category: Medical Device Job ID: 2012-5544 Career Level: experienced Location/Division: Davol Inc / Warwick, RI Relocation: no Posted Date: 4/10/2012 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: Advanced Quality Engineer Davol Inc. Warwick, RI The position of Advanced Quality Engineer is responsible to represent quality on design teams and assure that new product designs and the processes for manufacturing them meet all Corporate and Divisional requirements with respect to product quality, safety and efficacy. This individual will be an active team member and collaborator on new product development and product enhancement project teams for implantable medical devices. Summary of Position with General Responsibilities: •Support design and development activities for new product development including regulatory submissions. •Lead product and process risk assessment activities such as Hazards analysis, and Design Failure Modes & effects Analysis (DFMEA). •Support design validation and process validation activities. •Lead shelf life/stability testing activities for new products. •Develop, document and validate inspection and test methods to support design verification/validation, in-process inspection, and final inspection activities. •Support Product/Process Transfers from Pilot facilities to Manufacturing Facilities. •Evaluate product complaints and initiate corrective actions as needed to improve product quality and work with manufacturing facilities in resolving quality issues. •Provide technical support to resolve quality problems in development, pilot, manufacturing or with suppliers as warranted. Basic Qualifications: •Bachelor Degree in Technical discipline required. •3 years minimum experience in Quality Engineering discipline including design controls, product/process validation, and technical problem solving. •Strong design control experience in a medical device environment. •A high level of competence in Quality Technology including statistical techniques and six sigma tools. •Applied knowledge of the requirements of FDA QSR’s and ISO Quality Systems. Additional Desirable Qualifications Skills and Knowledge: * Demonstrated collaboration and leadership skills on New Product Development Teams. * CQE and/or Six Sigma certification a plus.2012-04-11 12:36:02United StatesC. R. BardRhode IslandNoneRIWarwick, RI27814905http://crbard.jobs/xml/27814905/jobUSAWarwickSr. Regulatory Affairs Specialist Industry Title /Category: Medical Device/Regulatory Affairs Job ID: 2012-5391 Career Level: experienced Location/Division: Warwick, RI/Davol Relocation: No Posted Date: 1/6/2012 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: Sr. Regulatory Affairs Specialist Davol Inc. Warwick, RI The position of Regulatory Affairs Specialist will provide technical and administrative regulatory support to ensure timely introduction of new products subject to medical products regulations. Provide regulatory support to marketed products. Summary of Position with General Responsibilities: •Prepare and submit applications to the FDA for clinical testing and marketing of new/modified medical devices (e.g., 510(k)’s, IDE’s, PMA’s). •Assist in determination of the appropriate regulatory submission requirements and strategies for new or modified products. Prepare required documentation as needed (e.g., No 510(k) Rationales). •Coordinate review of FDA submissions and test protocols with Corporate Regulatory, Medical and Legal Departments, and respond to any questions posed by these departments or the FDA. •Prepare applications for international marketing approvals (i.e. CE Mark Technical files and Dossiers, JSTD). •Assist Product Development and Quality Assurance in planning pre-clinical studies and bench testing that will ultimately be used in regulatory submissions. •Assist in the review of proposals for clinical design validations, clinical field trials and customer preference tests. •Represent regulatory affairs on product development teams to provide direction with respect to regulatory/clinical requirements and strategy. •Assist in development of new product instructions for use/promotional material. Review product labeling for compliance with medical device regulations and Division/Corporate Policies. •Provide marketed product regulatory support for change management activities, product registrations, and business improvement activities. Basic Qualifications: - B.S. degree or equivalent with emphasis on Life Sciences. Professional certifications preferred. - Knowledge and experience 4-6 years with regulatory requirements for medical devices including submission of IDE’s, PMA’s and 510(k)’s, and CE mark technical files. Additional Desirable Qualifications Skills and Knowledge: * Professional certifications preferred. * Good oral and written communications skills and ability to work on cross-functional teams. * Working knowledge of statistics and electronic documentation and information systems. * Ability and desire to travel as needed.2012-01-06 21:46:25United StatesC. R. BardRhode IslandNoneRIWarwick, RI25749627http://crbard.jobs/xml/25749627/jobUSAWarwickSenior Advanced Quality Engineer Industry Title /Category: Medical Device Job ID: 2011-5116 Career Level: experienced Location/Division: Davol / Warwick, RI Relocation: Yes Posted Date: 6/29/2011 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: Sr. Advanced Quality Engineer Davol Inc. Warwick, RI The position of the Senior Advanced Quality Engineer is responsible to assure that new product designs and the processes for manufacturing them meet all Corporate and Divisional requirements with respect to safety and efficacy. This individual will represent quality interests and concerns on project teams and report to the Manager of Advanced Quality Engineering. Summary of Position with General Responsibilities: *Provide technical guidance to Quality Engineers, Quality Technicians, and Inspectors as required based on level. *Lead or Support Quality Engineering Projects to improve Quality Systems and Procedures. *Development of Test Protocols and Final Reports to support Regulatory 510K or PMA submissions. *Development of Risk Management Documents, including the DFMEA, while coordinating input from the other Design Sub-team members. *Development of the Design Verification Protocol and Design Verification Report. *Provide input into the product Design Inputs, Design Outputs, Product Specifications, Product Development Plans, and applicable design control documents as defined per Davol’s product development process. *Support front end product innovation process activities to support new technology integration and transfer to new product development teams. *Determine the degree of Biocompatibility testing required as per ISO10993 requirements. *Develop test protocols and release a final report on Shelf Life Studies in support of expiration dating. Lead Supplier part qualification activities. *Perform test method validations to ensure accuracy, precision, selectivity, sensitivity, stability, and reproducibility of test methods used to assess the safety and efficacy of devices. Basic Qualifications: •Bachelor Degree in Engineering or Technical Sciences or equivalent combination of Bachelors Degree and related work experience. •Senior AQE (5-7) year’s minimum experience in Quality Engineering discipline including design controls, product/process validation, supplier management, and technical problem solving. •An appropriate level of competence in Quality Technology including statistical techniques and six sigma tools including sampling plans, process capability analysis, gage R&R, hypothesis testing, analysis of variance, regression, and design of experiments. •Applied knowledge of the requirements of FDA QSR’s and ISO Quality Systems. Additional Desirable Qualifications Skills and Knowledge: * CQE certificate from American Society for Quality a plus. * Ability to work with and motivate people. * Good oral and written communication skills.2011-06-29 22:11:26United StatesC. R. BardRhode IslandNoneRIWarwick, RI22090735http://crbard.jobs/xml/22090735/job