US-CO-Englewood: Quality Engineer
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please visit http://sqa.fyicenter.com
* 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.
* Bachelorís degree in engineering or physical science.
* Medical device and FDA experience helpful.
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Team SQAFYI - Software QA Resource FYI