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Quality Engineer
Ref No.: 18-05051
Location: Franklin Lakes, New Jersey
Objective Individual with thorough experience in quality engineering, quality systems, validation, risk management and design control for a market leader in the medical device industry. Summary of Skills • Extensive knowledge of quality engineering, and or quality systems for medical devices • In-depth knowledge of the concepts of; design control, engineering change control, statistical techniques, verification and validation methods/protocols, risk management, design history files (DHF), device history and master records (DHR/DMR), CAPA, 510(k) etc. • Well-versed in the methodologies of verification and validation for medical devices • Sound knowledge of FDA Quality System Regulations; 21 CFR Part 210, 211, especially 21 CFR Part 820 etc. • Sound knowledge of ISO13485 for medical devices • Quality engineering concepts such as; statistical analysis, measurement and calibration systems, quality testing, sampling and inspection, process control, SOPs, engineering change notices etc. • Audit experience a plus • Knowledge of basic computer applications, Microsoft suite of tools (Word, Excel, Power Point etc.), Minitab for statistical analysis, SAP a plus • Can communicate effectively • Must be able to work under minimal supervision on somewhat ambiguous tasks Work Experience • Medical Device Quality Engineer/Quality Systems Engineer/Quality Auditor • About five (5) plus years of experience within FDA regulated medical device and or pharmaceutical industry with knowledge of FDA and ISO regulations Education and Certifications • Bachelor's Degree in a scientific discipline • ASQ CQE, CQA, Six Sigma certification a plus Additional Job Description • Assist in special assignment to support regulatory gap analyses