Quality Engineer - Medical Devices Posted Feb 15
Modis , 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

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

Employment Type: Contract
Duration: 6 months

Pay: 55 to 60 EUR (Euro)
Pay Period: Hourly