Quality Engineer - Medical Devices Posted Feb 15
Modis , Bordeaux, Gironde, France
 
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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

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