Quality Assurance Manager (Process)

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 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