Description:
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 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
Work Experience
• 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
