Provide quality engineering support in the design and development of medical device products and facilitate the application of design controls, translate 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 - Skilled in test plan development and root cause failure analysis - Skilled in statistical methods including ANOVA statistical process control sampling plans gauge R&R and design of experiments - Good verbal (including presentation) and written communication skills especially technical report writing - Ability to effectively work on project teams - Familiar with reliability analysis and test methods - Familiar with ISO 14971 or strong experience in risk evaluation techniques such as FMEA and/or fault tree analysis - CQE certification desirable. All inquiries and resumes will be kept in strictest confidence.
• EDUCATION: Bachelor of Science degree in an engineering discipline EE preferred
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