Katalyst Healthcares and Life Sciences
Roles & Responsibilities:
- CAPA and non-conformance experience required.
- Investigation experience required.
- Managing system.
- 6-7 years' experience.
- Bach degree required.
- Preferred exp in Med Device but not required.
- Performs Quality and technical review of Nonconformance investigations (Company) and CAPAs within defined timeframes. Ensures investigations and root cause analysis are accurate and complete.
- Maintain an accurate log of Non-Conformances and CAPAs activities. Tracks, follows-up and assists in the timely closure of Company/CAPAs.
- Provides hands-on guidance and training to all personnel performing activities within the Quality system.
- Ensure documentation is complete before closure.
- ssist Quality Systems team as needed to investigate Nonconformances and ensure proper implementation of CAPAs.
- Prepare monthly and quarterly metrics to present at Quality Review meetings.