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Quality Engineer

The Reserves Network Westford Full-Time
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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 Lisa Fortier at Phone number blocked - click to apply

If interested please send a resume to: URL blocked - click to apply

 

Skills required

Resolve Quality Issue
Perform Statistical Analysis
Sample Procedure
Use Statistical Tool
Use Quality Tool
Resolve Issue

Location

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$94K
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Quality Engineer
Estimated Salary: $89K
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Job ID: 4621235

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The Reserves Network provides Total Staffing
Solutions, offering temporary, temp-to-hire and direct hire job opportunities
in the office, industrial, professional and technical markets. 



Since 1984, The Reserves Network has worked as an employment "match-maker"
- bringing thousands of job seekers and employers together in a multitude of
industries at our 40 operating locations throughout the Midwest, Southeast and
Northeast. 



Headquartered in Cleveland, Ohio, The Reserves Network is a Veteran and
family-owned company, that has been awarded for excellence in growth,
management and customer service excellence. The origin of the company's name
and its red, white and blue colors can be traced back to Founder & Chairman
Don Stallard and his experience as an officer and pilot in the Air Force,
particularly the time he spent in the U.S. Air Force Reserves. 



The Reserves Network exists to provide superior customer service through
Quality, Reliability, and Integrity in our every interaction.

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