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Engr 3, Quality
Ref No.: 18-27998
Location: Franklin Lakes, New Jersey
Start Date / End Date: 07/02/2018 to 01/31/2019
Job Summary
Company: Artech Information Systems LLC
Position:   Engr 3, Quality
Location:  Franklin Lakes, NJ 
Duration:  6+Months
Job Reference Code: CFNJP00021032

Job Description:
  • 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 

Thanks and Regards,
Sai Paramita
Sr. Technical Recruiter
Artech Information Systems LLC
360 Mt. Kemble Avenue, Suite 2000 | Morristown, NJ 07960
Office: 973.967.3552 | Fax: 973.998.2599
Email: Sai.Paramita@artechinfo.com