Engr , Quality

Quality Engineer

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 ISO
  13485 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