Contacts: This position interacts with all levels of employees & suppliers (& internal customers) appropriately.
Position Scope & Purpose:
Maintains quality standards by sampling, inspecting & labeling (physical & mechanical checks & tests) of incoming materials & components as used in the manufacture of molded parts, sub-assemblies & finished medical devices as per control plans, SOPs & WIs. Assures accuracy & correctness of data & maintains inspection results in Device History Records.
Key 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 recent 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; input
📌 Quality Inspector (Bengaluru)
🏢 SMC
📍 Bengaluru
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