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.

Apply here: https://forms.gle/BFC1URkPJQDu1MBo7

Contact details: [email protected] | 6358944452

For more details: Visit career page at www.medinnovasystems.com