US-CA-Menlo Park: Principal Quality Engineer
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please visit http://sqa.fyicenter.com
Principal Quality Engineer
Duties & Responsibilities:
* Represents the QA Department on all phases of the Product Development Cycle starting from early design stages to product implementation in manufacturing. Ensures compliance with Design Control requirements.
* Establishes the strategy for development of electronics and software for medical devices including embedded software V&V.
* Authors/approves software and electronics requirements, V&V plans, protocols and reports, test case scripts, risk assessments, traceability matrices, and other documents supporting software and electronics development.
* Conducts thorough review and approve design and process documentation such as component specifications, design verification and design validation protocols and reports, process validations protocols and reports etc.
* Leads the development of quality documentation for Risk Management, biocompatibility, shelf life testing, package integrity/transit testing studies, First Article Inspection, incoming and in-process inspections, lot release testing and failure analysis. Supports Engineering Builds.
* Represents Company in contacts with regulatory agencies, including interface with FDA inspectors and presentations to FDA management personnel.
* Performs software supplier audits.
* BS degree in Electrical Engineering or BS degree in technical or scientific discipline with multiple courses in embedded software and electronics.
* 5+ years experience in embedded software and electronics for medical devices.
* 10 years experience in medical device manufacture.
To apply for this position, please visit
Team SQAFYI - Software QA Resource FYI