Senior 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.
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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.
