US-CA-Menlo Park: Principal Quality Engineer To apply for this position, please visit this Website. http://sqa.fyicenter.com/jobs/99675053_Principal_Quality_Engineer.html To see other opportunities, please visit http://sqa.fyicenter.com Date: 01-Jan-2010
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. Qualifications: * 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. Thank you, Team SQAFYI - Software QA Resource FYI http://sqa.fyicenter.com -- You received this message because you are subscribed to the Google Groups "Software Quality Assurance Center" group. To post to this group, send email to [email protected]. To unsubscribe from this group, send email to [email protected]. For more options, visit this group at http://groups.google.com/group/software_qa_center?hl=en.
