Quality Assurance & Regulatory Affairs Engineer (QARA)
- Hiring Organisation
- Hays
- Location
- Swindon, Wiltshire, South West, United Kingdom
- Employment Type
- Contract
successful in this role, you will ideally have: Experience within Medical Devices, Diagnostics or another highly regulated manufacturing environment. Strong knowledge of ISO 13485 and Quality Management Systems. Experience managing CAPAs, non-conformances, complaints and root cause investigations. Knowledge of quality tools such as 8D, 5 Why, Fishbone … process improvement initiatives. Exposure to supplier quality, change control and risk management activities. Strong documentation and problem-solving skills. Experience with Technical Documentation, ISO 14971, UK MDR, EU MDR, Design Controls or validation activities would be advantageous. Excellent stakeholder management and communication skills. Please note: sponsorship is not available ...