SQAFYI - Software QA Resource - FYI

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

US-CA-: Senior Quality Engineer