Quality Engineer - Medical Devices
Posted Feb 15
Bordeaux, Gironde, France
This employer requests that only candidates in France apply to this job.
You appear to be located in United States, not France, so you will not be able to apply for this job.
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
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
Employment Type: Contract
Duration: 6 months
Pay: 55 to 60 EUR (Euro)
Pay Period: Hourly