Quality Assurance Engineer (Manufacturing)

Quality Assurance Engineer (Manufacturing Process Validation, Medical)

Cardiff, Bristol

To £35k

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 medical devices Quality Engineer to provide Quality Assurance and test of existing manufacturing process and provide quality assurance and development of new manufacturing process 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