1 year contract assignment for a Quality Engineer for a Medical Device company.
Performs gap assessments between Quality System procedures and EU Medical Device
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
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
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
Multiple Healthcare Plans
Accident, Disability, Life
Direct Deposit/Pay Cards
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
Resolve Quality Issue
Perform Statistical Analysis
Use Statistical Tool
Use Quality Tool