Quality Engineer (Process Validation, Medical)

Quality Engineer (Process Validation, Medical)

Newport area

To 40k

Our client is an innovative medical device company specialising in the design and development of cutting edge electro-mechanical medical devices and due to steady growth they now have an immediate requirement for a Quality Engineer to provide Process Validation and Verification for new product manufacturing capacity in accordance with regulatory requirements

Responsibilities:
* Ensuring manufacturing process validation activities are compliant with medical devices standards ISO 13485, FDA 21 CFR Part 820, MDD
* Develop verification and validation and test method qualification
* Generate of process validation plans and validation documentation
* Risk analysis and FMEA
* Statistical analysis (sampling and proving) of validation results
* Provide Quality Engineering expertise throughout the design and manufacturing process

Education and Experience
* HND or equivalent calibre in engineering
* Quality, process development and process validation for medical devices
* Formal process development and problem solving environments
* IQ/OQ/PQ or similiar processes and statistical techniques

Job Type : Permanent

Location : Cardiff, Newport, Bridgend, Swansea, Bristol, South Glamorgan, Mid Glamorgan, Gwent, Monmouth, Gloucester, Ross-On-Wye

Salary : to 405k

Date Advertised : 13 Nov 2012


Sorry, this position is no longer available.

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