Senior Quality Assurance and Regulatory Affairs Engineer
- Hiring Organisation
- Hays
- Location
- Swindon, Wiltshire, South West, United Kingdom
- Employment Type
- Permanent
need to succeed You will have: Previous Quality Engineering experience within medical devices or another highly regulated manufacturing environment Strong knowledge of ISO 13485 and medical device quality systems Experience managing non-conformances, CAPA and root-cause investigations Knowledge of quality tools such as 8D, 5 Why, Fishbone … Good knowledge of UK MDR and EU MDR, particularly Technical File generation, maintenance or remediation A relevant engineering, scientific or technical qualification Experience with ISO 14971, design controls, process validation, complaint handling, supplier quality or internal auditing would be advantageous. What you'll get in return You will receive ...