Quality Assurance Coordinator

With general guidance, coordinates the day-to-day activities of the Quality Assurance department, including: audits of Packaging and Distribution materials and goods, as well as activities, within an FDA regulated environment to ensure conformance to external regulations, as well as CooperVision’s rigorous quality standards. Trains or assists in training of new employees, while auditing trainees and engaging in dialogue with leadership in regards to progress. Works under minimal supervision.

1. Supports and participates in project meetings related to Medical Device Regulation (MDR), providing updates, tracking action items, and ensuring timely completion of deliverables.
2. Performs New Product Verifications (NPVs) in support of MDR requirements and business operations, including both routine day-to-day NPV and project-related activities.
3. Develops and maintains an NPV tracking log to document all completed verifications and identify recurring causes of successes and failures.
4. Initiates and processes Nonconformance Reports (NCRs) for all failed NPVs, ensuring accurate documentation, investigation, and follow-up of quality issues.
5. Will work cross functionally with the MDR team
6. Coordinates the daily activities within the Quality Assurance (QA) department with respect to prioritizing and organizing the daily workflow for the auditors.
7. Monitors and enforces compliance to Quality System Regulations (QSR).
8. Reports [to management] deviations from established procedures or product standards.
9. Serves as a resource to the QA Auditors when interpreting quality standards.
10. Trouble shoots and problem solves as needed.
11.  Conducts document review of specifications to ensure procedures and product quality have been maintained.
12. Assists in process development, performing approved protocols, validations and qualifications through direction from leadership.
13. Updates SOP’s (standard operating procedures) and creates deviations.
14. Creates NCR’s (non-conformance reports); audits re-worked non-conformances.
15. Capable of performing verification audits to packaging lines and reporting the information accurately on required forms per SOP (standard operating procedure) guidelines includes responsibility for product release
16. Assists in internal audits including audits of: department’s procedures, processes and training records, to support approved protocols, validations and qualifications.
17. Assists leadership in establishment of product defect criteria.
18. Trains or assists in training of new employees; performs audits on trainees to provide feedback to leadership on training progress.
19. Fills in, as needed, on day-to-day audit activities.
20. Continuously challenges the process as part of CooperVision’s Continuous Improvement culture.
21. Serve as support to supervisor/management as necessary regarding performance and processes throughout the department while present, and a backup in the absence of supervisor/management.
22. Performs other duties as assigned.
23. As business needs dictate, works extended hours to complete daily department goals or tasks to include mandatory overtime.