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| Job Location | Bangalore |
| Education | Not Mentioned |
| Salary | Not Disclosed |
| Industry | Manufacturing |
| Functional Area | Engineering Design / Construction,Maintenance |
| EmploymentType | Full-time |
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 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.
Technical/Functional Skill Sets:
1. Quality inspection of plastics injection molded assembled medical devices.
2. Quality Management Systems (QMS) Requirements (QA / QC) - preferably ISO 13485.
3. Good mechanical aptitude, arithmetic, analytical quality engineering technical process engineering experience in trouble shooting process improvement.
4. General proficiency in computer applications like Minitab, MS Word, Excel, PowerPoint, Outlook, etc.
Personal Qualities/Characteristics required for the position:
1. While performing the duties of this job, the employee is regularly required to stand; walk, sit for extended periods of time.
2. Should be willing to work in night shifts weekends.
,Keyskills :
qualityisoquality standardsraw materialsfirst article inspectioncalibrationmusic makingiso 13485root causeinspectionroot cause analysismedical devicesquality controlcorrective actionquality managementquality inspectionshop floortechnical