Senior Quality Engineer

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.

Closing Date:
Contact Details:
Contact: Josh McLachlan

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