Job Summary:
The Quality Systems Supervisor is responsible for overseeing the implementation and monitoring of key quality indicators, conducting checks and reviews of manufacturing operations, and reviewing batch records. This role involves managing incoming materials testing laboratories and site retains processes, completing final QA releases on all incoming components, and participating in site commissioning and qualification programs.
1. Collaborate with manufacturing and engineering functions to promote quality awareness and implement improvements to ensure product quality.
2. Implement and monitor key quality indicators within manufacturing processes to identify unexpected events and preventive measures.
3. Conduct checks and reviews of manufacturing operations to monitor factors affecting product quality.
4. Review and evaluate internal executed batch records to facilitate product disposition for release.
5. Manage the incoming materials testing laboratory and site retains process.
6. Complete final QA releases on all incoming components.
7. Manage the incoming components team.
8. Participate in site commissioning and qualification programs.
9. Review and participate in deviations and changes to manufacturing operations.
10. Support complex site and third-party investigations.
11. Present issues to the QP clearly and concisely.
12. Manage on-hold and reject lists for the site.
13. Ensure continuous product quality through the quality system.
14. Support third-party activities, including:
* Product launches (MDR site of QP release, MDR acting as MAH oversight & market extensions).
* Review of changes from third parties, generating MDR change control and working with regulatory teams to understand impact on dossiers.
* Generate MDR PQR based on PQR provided by third-party – work with third-party to resolve issues.
* Prepare documents to support regulatory submissions (e.g., QP declaration, technical agreements).
15. Build strong communication with third parties and be point of contact during product launch and commercial activities.
16. Maintain oversight of on-site/third-party operations.
17. Participate in self-inspections.
18. Use quality risk management to ensure manufacturing operations are adequate.
19. Support the operation of the site training system, including preparing and presenting relevant training material, as required.
20. Stay up-to-date with regulatory initiatives and new guidance/requirements.
21. Ensure compliance with applicable regulatory guidance documents while driving improvements in product and process quality.
22. Support and execute other duties as assigned.