US-CO-Englewood: Quality Engineer
To apply for this position, please visit this Website.
http://sqa.fyicenter.com/jobs/99672032_Quality_Engineer.html
To see other opportunities, please visit http://sqa.fyicenter.com
Date: 23-Aug-2010

Quality Engineer

* Manages and performs V&V and process validation testing.
Demonstrates commitment to project team results and assists other team
members in meeting their goals. Contributes to project planning
process. Adjusts to multiple demands and shifting priorities. *
Provides leadership and guidance in the area of Design Control. *
Interprets data and provides judgment to influence decisions.
Effectively communicates complex information throughout organization,
both verbally and in writing. * Have a thorough understanding of
product and process validation, gauge R&R, measurement capability
methods, and failure analysis. Act as a liaison between new designs
and shop floor implementation. * Have a thorough understanding of
human factors engineering. * Experience in evaluating risk through
formal risk analysis, PFMEA, FMEA, fault tree analysis, and other
recognized tools. * Understands and demonstrates relationship between
patient safety and project responsibilities. * Act as the Voice of
Quality on cross functional teams. * Authors Quality System procedures
used to run the company. * Evaluates, selects, and applies standard
engineering practices. * Effective project and time management skills
to handle multiple projects and complete assignments with a minimal
supervision. * Expert knowledge in the application of consensus
standards and methodologies related to medical devices and engineering
tests. * Excellent technical and business writing skills for plans,
protocols, and reports. * Practical experience with the risk
management and design control processes. * Ability to influence
decision and work effectively in cross-functional teams. * Bachelor’s
degree in engineering or physical science. * Medical device and FDA
experience helpful.


Thank you,
Team SQAFYI - Software QA Resource FYI
http://sqa.fyicenter.com

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