Description
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.