Quality Inspector
2 weeks ago
Key Responsibilities, Accountabilities & Essential Functions:
1. Performs receiving inspections (visual & dimensional) on incoming raw materials, packing materials & components purchased, as per defined specifications.
2. Performs monitoring of key process inputs & process variables & communicates the shop-floor process adjustments, as may be required, to the appropriate production personnel & work with them.
3. Performs in-process inspections (visual & dimensional) on components being produced &/or packed in the prescribed packing materials, as per defined specifications.
4. Rejects nonconforming materials & components by segregating, labeling & quarantining the lots Communicates & reports the nonconformity to supervisor.
5. Participates in new product developments & process validation per protocols. Reads & perform first article inspection (FAIR) as per drawings using inspection guide sheets & standard & custom gages.
6. Performs inspections on finished products before they are packed in cartons, stored & palletized for shipping, as per defined specifications &/or as per customer requirements.
7. Monitor & maintain the critical measuring equipment & instrumentation to ensure proper operation.
8. Coordinate periodical calibration of all measuring & monitoring devices & fixtures.
9. Supports investigating root cause analysis & corrective & preventive actions for customer complaints.
10. Control of QMS documents & retention of records.
11. Documents inspection results by completing reports & logs; inputting data into quality database.
12. Maintains safe & healthy work environment (cleanroom) by following standards & procedures.
13. Assist in the writing & updating inspection checklists & reports.
14. Evaluate problems & make initial recommendations for possible corrective action to supervise.
Preferred Technical _I_ Functional Skill Sets:
1. Quality inspection of plastics injection molded & assembled medical devices.
2. Quality Management Systems (QMS) Requirements (QA _I_ QC)
- preferably ISO 13485.
3. Good mechanical aptitude, arithmetic, analytical quality engineering & technical process engineering experience in trouble shooting & process improvement.
Equipment Used: Working knowledge of various metrology devices like Vision Measurement System (VMS), Co - ordinate Measuring Machine (CMM), Vernier Caliper, Micrometer, Height Gauge, etc.
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