1. Ensure quality at all stages of manufacturing, including Incoming Inspection, SMT/PCBA, Mechanical Assembly, Display Assembly, Software Loading, Calibration, Functional Testing and Final Inspection.
2. Handle quality assurance activities for medical electronic equipment and patient monitoring devices.
3. Implement and maintain ISO 13485 Quality Management System.
4. Perform risk assessment, Hazard Analysis, FMEA and Risk Management as per ISO 14971.
5. Ensure compliance with IEC 60601-1 Electrical Safety Standards.
6. Handle PCBA/SMT quality inspection, ESD control and process quality.
7. Conduct electrical safety testing, including Ground Continuity, Leakage Current and Dielectric Strength/Hi-Pot Testing.
8. Prepare and maintain PFMEA, Control Plans, Inspection Reports and Quality Documentation.
9. Conduct Internal Audits, identify quality issues and implement CAPA.
10. Support Current Product Development, Product Validation and Mass Production.
11. Monitor product performance, identify defects and drive continuous improvement.
📌 Urgent opening || Quality Engineer || Pune
🏢 HR Mind
📍 Pune
Reply to this offer
Impress this employer describing Your skills and abilities, fill out the form below and leave Your personal touch in the presentation letter.