Senior QA Engineer

Medinnova Systems Pvt. Ltd.; Poicha; On-site; INR 600,000 - 1,000,000; Full time

Job summary

Medinnova Systems Pvt. Ltd. in Poicha, Gujarat seeks a Senior QA Engineer to strengthen QA for cardiac and hospital medical equipment.

You will lead technical QA activities, work with R&D on product development and documentation, and ensure conformity to ISO 13485, FDA/CE standards, and design controls.

Responsibilities

• Handle technical QA activities for medical devices and healthcare equipment.
• Work closely with R&D on product development, design and technical documentation.
• Finalize Design Inputs, Design Outputs, Design Reviews, Verification and Validation documents.
• Support Risk Management activities as per ISO 14971.
• Finalize product specifications, drawings, BOMs, technical requirements and acceptance criteria.
• Review Engineering Change Notes (ECN), design changes and technical modifications.
• Ensure proper revision control and traceability of technical documents.
• Perform and review product testing using test fixtures, measuring instruments, vernier calipers, micrometers, electrical safety analyzers and other applicable testing equipment.
• Conduct product testing, verification, validation and inspection results against approved specifications.
• Review packaging, packing and transportation requirements as per applicable FDA/CE standards and customer requirements.
• Support UDI, product labelling and export shipment technical documentation.
• Review manufacturing and inspection records for product conformity.
• Coordinate with R&D, QC and Production for technical quality issues.
• Investigate product and process non-conformities and support root cause analysis and CAPA.
• Prepare and review technical documentation in accordance with applicable ISO 13485, IEC, FDA, CE and other regulatory requirements.
• Support preparation and review of technical documentation for FDA, CE and other regulatory submissions.
• Maintain product technical files, DHF and related technical records as applicable.
• Review technical requirements for Heart-Lung Machines, Heater-Cooler Systems, OT Rooms and related medical equipment.
• Evaluate product changes and technical issues in coordination with R&D.
• Verify completion of applicable production, inspection and testing records before product release.
• Authorize product release based on conformity with approved specifications, inspection requirements and applicable quality records.
• Ensure non-conforming products are not released without authorized disposition.
• Support technical aspects of internal, external, certification and regulatory audits.
• Maintain strong technical knowledge of medical devices, testing methods and applicable standards.
• Identify technical and quality gaps and coordinate corrective actions with R&D, QC and Production.

Education

Bio medical

Electrical

Electronic And Communications

Job description

Job Title: Senior QA Engineer

Experience: 2–3 Years

Qualification: Bio medical , Electrical , Electronic And Communications

Department: Quality Assurance

Industry: Medical Devices / Healthcare Equipment

Product Scope: Cardiac and hospital medical equipment, including Heart-Lung Machines, Heater-Cooler Systems, OT (Operation Theatre) Rooms and related medical equipment.

Key Responsibilities

1. Handle technical QA activities for medical devices and healthcare equipment.
2. Work closely with R&D on product development, design and technical documentation.
3. Finalize Design Inputs, Design Outputs, Design Reviews, Verification and Validation documents.
4. Support Risk Management activities as per ISO 14971.
5. Finalize product specifications, drawings, BOMs, technical requirements and acceptance criteria.
6. Review Engineering Change Notes (ECN), design changes and technical modifications.
7. Ensure proper revision control and traceability of technical documents.
8. Perform and review product testing using test fixtures, measuring instruments, vernier calipers, micrometers, electrical safety analyzers and other applicable testing equipment.
9. Conduct product testing, verification, validation and inspection results against approved specifications.
10. Review packaging, packing and transportation requirements as per applicable FDA/CE standards and customer requirements.
11. Support UDI, product labelling and export shipment technical documentation.
12. Review manufacturing and inspection records for product conformity.
13. Coordinate with R&D, QC and Production for technical quality issues.
14. Investigate product and process non-conformities and support root cause analysis and CAPA.
15. Prepare and review technical documentation in accordance with applicable ISO 13485, IEC, FDA, CE and other regulatory requirements.
16. Support preparation and review of technical documentation for FDA, CE and other regulatory submissions.
17. Maintain product technical files, DHF and related technical records as applicable.
18. Review technical requirements for Heart-Lung Machines, Heater-Cooler Systems, OT Rooms and related medical equipment.
19. Evaluate product changes and technical issues in coordination with R&D.
20. Verify completion of applicable production, inspection and testing records before product release.
21. Authorize product release based on conformity with approved specifications, inspection requirements and applicable quality records.
22. Ensure non-conforming products are not released without authorized disposition.
23. Support technical aspects of internal, external, certification and regulatory audits.
24. Maintain strong technical knowledge of medical devices, testing methods and applicable standards.
25. Identify technical and quality gaps and coordinate corrective actions with R&D, QC and Production.