Description
I am currently seeking a Quality Engineer with a background in medical devices to work with a client of mine based in France, some key information regarding the position is as follows:
Duration: 6 months+
Location: Bordeaux, France
Experience in Class II or Class III Medical Device manufacturing preferably implants/instruments; Class I experience at this time is not relevant to current scope.
Must be fluent in French and English
21 CFR Part 820 Subpart G - Production and Process Controls
ISO 13485 - Medical Device and Quality Systems
Medical Device Production Part Approval Process (PPAP)
Unique Device Identification (UDI) is a plus
Knowledge of ISO 14971 - Medical Device (patient based) Risk Management pFMEA
Process Validation experience in Medical Device,
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
Experience with process monitoring of manufacturing process using Cpk and Ppk