Quality Engineer
Key Skills for This Role
Full Job Posting
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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About SMC Ltd.
Privately owned medical contract manufacturer serving medtech, diagnostics, and pharmaceutical companies with single-use devices and pharma services.
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