Provide quality engineering support in the design and development of medical device products and facilitate the application of design controls. This includes translating Quality Standards into processes and procedures and applying them to the product design process.
Requirements: 5+ years of quality engineering experience in a high volume manufacturing environment Test plan development and root cause failure analysis Experienced in statistical methods including ANOVA statistical process control sampling plans gauge R&R and design of experiments, work on project teams Familiar with reliability analysis and test methods Strong experience in risk evaluation techniques such as FMEA and/or fault tree analysis CQE certification desirable.
• EDUCATION: Bachelor of Science degree in an engineering discipline EE preferred
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