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Quality Assurance Manager (Process, V&V, Medical Devices) job in Newport

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Job Ref:  69212693
Employer:  My Job Matcher
Country:  United Kingdom
City:  Newport
Post Code:  GL13
10/10/2016 16:33
Quality Assurance Manager (Process Engineering, V&V, Medical Devices) Bristol, Cardiff To 50k 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 Assurance Manager to provide Quality Assurance expertise and Process Validation and Verification for new product manufacturing capacity in accordance with regulatory requirements Responsibilities: Experience of running a medical devices QMS, overseeing document control and product complianceEnsuring manufacturing process verification and validation activities are compliant with medical devices standards ISO 13485, FDA 21 CFR Part 820, MDDDevelop verification and validation and test method qualificationGenerate of process validation plans and validation documentationEquipment QualificationRisk analysis and FMEAStatistical analysis (sampling and proving) of validation resultsProvide Quality Engineering expertise throughout the design and manufacturing process and new product development Education and Experience HND or equivalent calibre in engineeringQuality, process development and process validation for medical devicesFormal process development and problem solving environmentsIQ/OQ/PQ or similiar processes and statistical techniques
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