1. Conduct routine quality control inspections and testing of products.
2. Ensure that all products meet quality specifications before release.
3. Manage and maintain QA/RA documentation, including SOPs, work instructions, and records.
4. Assist in the preparation and review of SOPs, ensuring they meet regulatory and quality standards. 5. Assist in document review and approval processes.
6. Gather data and documentation required for regulatory submissions.
7. Assist in preparing and compiling submission dossiers.
8. Conduct routine supplier assessments and audits.
9. Monitor supplier performance and manage supplier-related issues.
10. Participate in investigating non-conformances and customer complaints.
11. Assist in developing and implementing CAPA actions and track their effectiveness.
12. Provide training to new employees on QA/RA processes and procedures.
13. Ensure ongoing competency and training records for staff.
14. Ensure product labelling and promotional materials comply with regulatory requirements.
15. Assist in monitoring regulatory changes and updating company policies accordingly.
16. Collect and review customer-related documents and conduct data analysis to support QA/RA activities.
17. Collect and review PMCF forms and data, preparing reports for approval.
18. Support the preparation of clinical evaluation and risk management documents.
19. Conduct calibration activities, obtain necessary certificates, and assist in validation activities, including the preparation of protocols and reports. Review preventive maintenance records.
20. Review and approve dispatch activities to ensure product quality and compliance.
21. Participate in change control, new initiation, and deviation processes, ensuring proper documentation and implementation.
22. Manage the opening, closing, and reviewing of instrument usage logbooks across departments. 23. Conduct data analysis to identify trends and support continuous improvement efforts.
24. Prepare medical device and technical files, ensuring they meet regulatory requirements.
25. Review BMR to ensure accuracy and compliance before approval.
26. Assist in maintaining the MR file according to ISO 13485 requirements.
27. Prepare for and participate in MRM, documenting outcomes and action items.
28. Review labelling and packaging materials, assisting in maintaining Art master files.