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Coord 1, Quality Document Sys Mgmt
Ref No.: 18-02722
Location: Franklin Lakes, New Jersey
Position Type:Contract
Job Category:Admin/Secretarial
Benefits:Medical Insurance
Hiring a Contract  Document Control Assistant 
Duration: 3 month Assignment 
Client Location:  Franklin Lakes, NJ
Work Schedule:  Monday - Friday / 40 Hours Weekly
Pay Rate:  $17 Hourly 

Individual with thorough experience in quality engineering, quality systems, validation, risk manangment 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 ambigiuos 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 disclipline
•ASQ CQE, CQA, Six Sigma certification a plus
Assist in special assignment to support regulatory gap analyses

To Apply for immediate consideration please send resume to Michael Estaris at and reference job #18-02722 in the Subject Line and indicate the best times to contact you (please include nights and weekends if needed).
**Candidates must complete background and drug screenings before starting any assignment.
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