Job Description
Quality Engineer – South Wales – Medical Device
About the Company:
We are looking for a Quality Engineer from the Medical Device industry to work at an expanding company in south Wales. In this role you will provide quality support across manufacturing, sterilisation, packaging and the shipment of medical devices.
Responsibilities:
1. Provide practical Quality Engineering expertise across diverse projects, applying solid engineering principles to support timely and effective project execution.
2. Ensure effective implementation of Master Validation Plans to support site qualification and validation activities.
3. Lead validation programs for processes, computerized systems, and cleaning, including the creation and independent review of protocols and reports using sound statistical methodologies, with a strong focus on data verification and statistical analysis.
4. Lead investigations into complex product quality and compliance issues, identifying impact, root cause, and implementing corrective actions.
5. Implement and verify the effectiveness of corrective and preventive actions (CAPAs).
6. Manage product complaint handling in collaboration with Engineering and Operations teams.
7. Provide hands-on support for general and technical quality issues to enable timely decis...