Senior Quality Engineer

Job type:
Start date:
6 months
Published at:
flag_no France
Project ID:

This project has been archived and is not accepting more applications.
Browse open projects on our job board.

I am currently recruiting for a high profile Medical Device company they are looking for an experienced Quality Engineer to work on an important project.

An ideal candidate will have experience of the following:

  • 21 CFR Part 820 Subpart G - Production and Process Controls
  • ISO 13485 - Medical Device and Quality Systems
  • Must be Fluent in French and English
  • Computer Software Validation (CSV) as part of manufacturing process validations.
  • Medical Device Production Part Approval Process (PPAP)
  • Unique Device Identification (UDI) is a plus
  • ISO 14971 - Medical Device (patient based) Risk Management pFMEA (identification and control)
  • Process Validation experience in Medical Device, including creation and execution of protocols and reports.
  • Experience with Test Method Validation(TMV)/Measurement System Analysis (MSA) using
  • Ability to correctly determine specifications from prints.
  • Process Flow Maps
  • Control points
  • Reaction plan to prevent non-conforming product.
  • pFMEA control for risks included in process flow map
  • Quality System remediation experience
  • Experience with process monitoring of manufacturing process using Cpk and Ppk

If you are interested in this position please apply and I will be in contact with you to discuss the role and your experience in detail.