Quality Engineer

Westford, MA 01886

Posted: 06/18/2019 Industry: Engineering Job Number: 510775

1 year contract assignment for a Quality Engineer for a Medical Device company.

Performs gap assessments between Quality System procedures and EU Medical Device

   Regulation.

Develops quality plans for Quality System updates to changing regulations and standards.

Develops process flowcharts for use in creating Quality System procedures and processes.

Develops and implements procedures, forms and/or templates to assure compliance with    

   Quality System Regulation, EU Medical Device Regulation and ISO 13485:2016 as well as other

   International regulatory requirements.

Initiate and complete Quality System change orders in Agile

 

Requirements
Seven to ten years related experience in an FDA regulated industry with at least five years  

   recent experience in Medical Devices or equivalent combination of education and

   experience.

Excellent working knowledge of medical device regulations (21CFR), ISO 13485, Medical

   Device Directive, EU Medical Device Regulation (in particular) Certified Quality

   Auditor/Certified Lead Auditor desirable

Benefits:

         Multiple Healthcare Plans

         Dental

         Vision

         Accident, Disability, Life

         Direct Deposit/Pay Cards

         401(k)

         Referral Bonuses


 

Since 1984, The Reserves Network continues to partner with the finest employers to provide opportunities within the office, industrial, professional and technical markets. As a family- and veteran-owned company, we focus on candidate experience and workplace culture for the nearly 20,000 employees we place annually.

For more information contact our Wallingford office at 203-651-6612

If interested please send a resume to: ddurocher@trnstaffing.com

 

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