Quality Assurance Auditor (12hr Nights)

Audits 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. Immediately reports any and all nonconformance to established SOP’s (standard operating procedure); Utilizes process control tools [sampling/testing guidelines] to evaluate conformance to these standards, while actively engaging Packaging and Distribution personnel. Employee works under minimal supervision

1.Performs audits as directed by management that include, but are not limited to:

 a. Incoming raw materials (packaging consumable materials)

b. DHR (device history record) review, product label and package review, includes responsibility for product release c. Process audits to verify conformance within established quality standards, including advising, and working with, leadership on possible improvements.

 2. Reports [to management] deviations from established procedures or product standards.

3. Participates in problem solving with management, and through direct interaction with Packaging and Distribution staff.

4. Assists in process development, performing approved protocols, validations and qualifications through direction from leadership.

 5. Continuously challenges the process as part of CooperVision’s Continuous Improvement culture.

6. Performs other duties as assigned.

7. As business needs dictate, works extended hours to complete daily department goals or tasks to include mandatory overtime.