Engr 3, Quality
Previous Job
Engr 3, Quality
Ref No.: 18-09445
Location: Franklin Lakes, New Jersey
Quality Prin Engineer
Franklin Lakes, NJ
6 Months

Extensive knowledge of quality engineering and 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 820

• 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

• Medical Device Quality Engineering experience

• Eight (8) 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

•Assist in special assignment to support regulatory gap analyses