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. Apply here: https://forms.gle/BFC1URkPJQDu1MBo7 Contact details: [email protected] | 6358944452 For more details: Visit career page at www.medinnovasystems.com