The Role
This is an exciting opportunity for someone develop their career in Quality Assurance in a market leading, global medical devices company. You’ll be responsible for supporting the compliance team to ensure all required certification is maintained.
1. Complete internal audits in compliance with relevant standards (ISO 13485, 21 CFR, MDD/MDR and UKCA regulations)
2. Assist in the logging, investigating, and documenting of all non-conformities
3. Corrective and Preventative Action Reports (CAPA), Non-Conformity Reports (NC)
4. Assist in the logging, investigating, and documenting of all product complaints
5. Recall handling
6. Prepare trending analysis data whilst escalating any trends to a CAPA.
7. Create and revise Product Specification Documentation.
8. Oversee and track external supplier audits and completion of actions.
You
To apply for this role as Senior QA Associate our client is hoping for someone with the following skills and experience;
9. Ample experience in Quality Assurance specifically within medical devices
10. Good knowledge of MDR is desired
11. Knowledge of ISO 13485, ISO 9001 and knowledge of ISO 14001 is desirable
12. Experience of Internal Audit, ideally as a lead auditor (desired)
13. Experience of CAPA/Complaints and Root Cause Analysis.
14. Experience in writing processes compliant with standards.
15. Due to their location, you will need to have a driving licence and access to a vehicle on office days