Description
I am currently recruiting for a contract Quality Engineer to work on a 6 month contract in Bordeaux for a high profile medical device company.
They are looking for someone with experience in the following:
Essential skills required for the roles:
- 21 CFR Part 820 Subpart G - Production and Process Controls
- ISO 13485 - Medical Device and Quality Systems
- Computer Software Validation (CSV) as part of manufacturing process validations.
- Medical Device Production Part Approval Process (PPAP)
- Unique Device Identification (UDI) is a plus
- Process Validation experience in Medical Device, including creation and execution of protocols and reports.
- Experience with Test Method Validation(TMV)/Measurement System Analysis (MSA), Gage R&R
- 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
Please note:
Fluency in French and English required
If you you think this position is a good match for you please apply and I will be in contact ASAP to discuss in detail.
If you have any questions please contact me at (see below)