Key Accountabilities/Essential Functions:

1. To ensure Raw Material / Packing Material and finished goods testing in line with the SOPs.

2. To maintain device history records (DHR) & product release checklist for each lot.

3. To conduct inspections at in-process, in-coming and completes the final inspections.

4. To prepare technical documents like DMR & DHR.

5. To maintain microbial record in ISO class-7 & class-8 as per procedure.

6. Creating master documents to track calibration & latest version of documents and records.

7. To prepare control plan, FMEA & FAIR documents.

8. To prepare 8D and supplier CAPA reports.

9. Monitoring calibration activities.

10. Perform metrology activities & drawing reviews.

11. 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, MSA, run charts, etc.

4. Working knowledge of the ISO 13485 & ISO 9001standards.

5. FAIR inspection, DHR & control of documents.

Personal Qualities/Characteristics required for the position:

Good technical, analytical and trouble shooting skills.

Equipment Used:

1. VMS, CMM, Vernier caliper, micrometer, height gauge, etc.

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