Quality Assurance Manager (Process Engineering, V&V, Medical Devices)

Recruiter
SJB TECHNICAL RECRUITMENT LTD
Location
Cardiff (Caerdydd)
Salary
To £50k + benefits
Posted
17 Jun 2017
Expires
29 Jun 2017
Sector
Engineering
Quality Assurance Manager (Process Engineering, V&V, Medical Devices) South Wales 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 compliance - Ensuring manufacturing process verification and 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 - Equipment Qualification - Risk analysis and FMEA - Statistical analysis (sampling and proving) of validation results - Provide Quality Engineering expertise throughout the design and manufacturing process and new product development 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