- Location
- Manjusar GIDC Vadodara
- Type
- Full-time
- Department
- Engineering
- Seniority
- Senior
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
- 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.
Skills
FDARisk Management