/Category Medical Device
Job ID 2012-5580
Career Level experienced
Location/Division Davol / Warwick, RI
Posted Date 6/8/2012
Close Date ..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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Advanced Quality Engineer / Sr. Advanced Quality Engineer
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 and Performance Irrigation products.Support design assurance and development activities for product
Summary of Position with General
Lead product and process risk assessment activities such as Hazards analysis, and Design Failure Modes & effects Analysis
Support design validation and process validation
Lead shelf life/stability testing activities for new
Develop, document and validate inspection and test methods to support design verification/validation, in-process inspection, and final inspection
Support Product/Process Transfers from Pilot facilities to Manufacturing
Evaluate product complaints and initiate corrective actions as needed to improve product quality and work with manufacturing facilities in resolving quality
Provide technical support to resolve quality problems in development, pilot, manufacturing or with suppliers as warranted.
Bachelor Degree in Engineering or Technical Science
3 years minimum experience in Quality Engineering discipline including design controls, product/process validation, and technical problem
Strong design control experience in a medical device
Prior experience with electrosurgical devices a
A high level of competence in Quality Technology including statistical techniques and six sigma
Applied knowledge of the requirements of FDA QSR's and ISO Quality Systems.
Additional Desirable Qualifications Skills And Knowledge
CQE and/or Six Sigma certification a plus.
- Demonstrated collaboration and leadership skills on New Product Development Teams.