Key Accountabilities/Essential Functions:
- To ensure Raw Material / Packing Material and finished goods testing in line with the SOPs.
- To maintain device history records (DHR) & product release checklist for each lot.
- To conduct inspections at in-process, in-coming and completes the final inspections.
- To prepare technical documents like DMR & DHR.
- To maintain microbial record in ISO class-7 & class-8 as per procedure.
- Creating master documents to track calibration & latest version of documents and records.
- To prepare control plan, FMEA & FAIR documents.
- To prepare 8D and supplier CAPA reports.
- Monitoring calibration activities.
- Perform metrology activities & drawing reviews.
- Coordinates investigation, root cause analysis & corrective action.
Technical/Functional Skill Sets:
- Preferred skills in various metrology equipment, such as VMS, CMM programming, etc.
- Product & process validation requirements & implementation.
- Gauge R&R, CpK, PpK studies, IQ, OQ,PQ validation/qualification, MSA, run charts, etc.
- Working knowledge of the ISO 13485 & ISO 9001standards.
- FAIR inspection, DHR & control of documents.
Personal Qualities/Characteristics required for the position:
Good technical, analytical and trouble shooting skills.
Equipment Used:
- VMS, CMM, Vernier caliper, micrometer, height gauge, etc.
- Minitab software.
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