Key Accountabilities/Essential Functions 1. To ensure Raw Material / Packing Material and finished goods testing in line with the SOPs. 1. To establish & maintain documents for process validation. 1. Coordinating with cross-functional departments to complete tasks. 4. To prepare & review technical documents like DMR & DHR. 1. Work closely with staff to establish procedures, work instructions & reports. 6. Establish & maintain contact with external testing agencies. 7. Recording, analyzing and distributing statistical information. 8. Preparing quality documentation and reports by collecting, analyzing and summarizing information. 9. Supervising technical & laboratory staff. 10. Monitoring calibration activities. 11.
Monitoring metrology activities & drawing reviews. 12. Coordinates investigation, root cause analysis & corrective action. Technical/Functional Skill Sets
- 1. Preferred skills in various metrology equipment, such as VMS, CMM programming, etc.
- 2. Product & process validation requirements & implementation.
- 3. Gauge R&R;, CpK, PpK studies, IQ, OQ, PQ validation/qualification, DoE Analysis, etc.
- 4. Working knowledge of the 21 CFR Part 820, ISO 13485:2016 & ISO 9001:2015 standards.
- 5. Certified Internal Quality Auditor.