US-CA-: Senior Quality Engineer
To see other opportunities,
please visit http://sqa.fyicenter.com
Date: 18-Jun-2012
Senior Quality Engineer
* Developing /delivering design assurance artifacts required by design controls
* Facilitating Risk Management activities
* Providing guidance on design control compliance requirements
* Ensuring design control requirements are met
* Post market product/complaint investigations (as needed)
* Field action consideration investigations (as needed)
* Inspection and/or evaluation techniques for determining levels of quality during the receipt, manufacture and final test of product (post design transfer)
* Equipment, fixtures and methods required to perform inspections, including gage R&R's
* First article inspections and results
* Confirm and/or establish statistically valid sample sizes for design and process V&V's
* Perform or contribute to root cause investigations of commercialized product where design issues are suspected
* Requires a BS degree. Software Engineering, Electrical Engineering, Mechanical Engineering, Biomedical Engineering or similar degree as applicable to the discipline needed
* Certified Quality Engineer or Certified Software Quality Engineer a plus
* Prefer 10-15 years work experience in medical devices
* 5-10 years work experience as a Quality Engineer
* Medical product manufacturing experience
* Understanding of electro-mechanical systems and component drawings
* Ability to perform multiple tasks concurrently with accuracy
* Clear and effective communication skills
* Has intermediate to expert knowledge of commonly-used concepts, practices, and procedures within the Quality Engineering field
* Relies on good judgment and guidelines to perform the functions of the job
* Ability to communicate effectively both orally and in writing and to establish and maintain cooperative working relationships with persons contacted in the course of performing assigned duties
* Strong attention to details
* Ability to organize and prioritize workflow and to meet established timeframes
* Ability to maintain updated knowledge of procedures, products and activities of assigned area
* Ability to hear and speak to employees and outside business associates on the phone and in person
* Ability to see the letters and numbers on a personal computer screen and on memos, reports and other documents (near vision)
* Requires right and left hand coordination for the use of the personal computer
To apply for this position, please visit
this Website.
Thank you,
Team SQAFYI - Software QA Resource FYI
http://sqa.fyicenter.com
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