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 and Design Controls
• 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, Trackwise a plus
• Can communicate effectively
• Must be able to work under minimal supervision on somewhat ambiguous tasks
• Medical Device Quality Engineer/Quality Systems Engineer/Quality Auditor
• About three (3) to 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 assess FDA regulatory gap analyses
• Assist in special assignment to assess compliance to the new European MDR requirements
Certified Quality Engineer
(American Society For Quality) Asq Certified
Corrective And Preventive Action (Capa)
Certified Quality Auditor
Iso 13485 Standard