The Quality Inspector 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 for release of goods.
1. Performs receiving inspections (visual, dimensional & functional) on incoming raw materials, packing materials & components purchased, as per defined specifications &/or as per supplier certificates, so as to assure that they are within the acceptance criteria & approves them by labeling.
2. Rejects nonconforming materials & components by segregating, labeling & quarantining the lots. Communicates & reports the nonconformity to stores personnel &/or supplier as appropriate for necessary disposal action & corrective actions.
3. 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.
4. Performs in-process inspections (in-depth visual, dimensional & functional) on components being produced &/or packed in the prescribed packing materials, as per defined specifications, so as to assure that they are within the acceptance criteria &/or as per customer requirements & approves them by labeling & signing off.
5. Rejects nonconforming components & sub-assemblies by segregating, labeling & quarantining the lots.
6. 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.
7. Performs inspections on finished products before they are packed in cartons, stored & palletized for shipping, as per defined specifications &/or as per customer requirements, so as to assure that they are within the acceptance criteria & approves them by labeling.
8. Rejects nonconforming goods by segregating, labeling & quarantining the impacted packaging units as per procedure. Communicates & reports the nonconformity to production personnel for suitable corrective actions.
9. Monitor & maintain the critical equipment & instrumentation to ensure proper operation & calibration.
10. Coordinate periodical calibration of all measuring & monitoring devices & fixtures.
11. Supports investigating root cause analysis & corrective & preventive actions for customer complaints.
12. Control of QMS documents & retention of records.
13. Documents inspection results by completing reports & logs; summarizing re-work & waste; inputting
- data into quality database.
- Perform review of Device History Records & other documentation for compliance to established procedures & Good Documentation Practices.
- Keeps measurement equipment operating by following operating instructions.
- Maintains safe & healthy work environment (cleanroom) by following standards & procedures; complying with legal regulations.
- Understands guidelines, regulations (current updates) & GMP (Good Manufacturing Practices) Requirements – USP/ EP; USFDA 21CFR, CE Marking, EU Directives to assure that the products meet market government standards & safety regulations. Assists in regulatory stewardship support to corporate regulatory team.
- Assist in the writing & updating inspection procedures, protocol & checklists.
Evaluate problems & make initial recommendations for possible corrective action to supervise.
- Quality inspection of plastics injection molded & assembled medical devices.
- Quality Management Systems (QMS) Requirements (QA / QC) – preferably ISO 13485.
- Electronic Document Control; BOM review; Medical Devices - Risk assessment & risk control techniques.
- Good mechanical aptitude, arithmetic, analytical quality engineering & technical process engineering experience in trouble shooting & process improvement.
General proficiency in computer applications like Minitab, MS Word, Excel, PowerPoint, Outlook, etc.