We are looking for a detail-oriented QA skilled with experience in the Medical Device industry to manage Quality Assurance activities, maintain the Quality Management System (QMS), and ensure compliance with applicable medical-device regulations and standards.

Key Responsibilities
Maintain and improve the Quality Management System (QMS) in accordance with ISO 13485:2016.
Prepare, review, update, and control SOPs, Work Instructions, Quality Manuals, Forms, and Quality Records.
Handle document control, change control, deviations, non-conformances, and CAPA.
Support internal, external, customer, and regulatory audits and ensure timely closure of audit observations.
Prepare and maintain medical-device technical documentation, including DHF, DMR/DMF and Device Master File as applicable.
Support Design Control, Design Verification & Validation (V&V;), Design Transfer, and product lifecycle activities.
Participate in risk management activities in accordance with ISO 14971, including risk assessment, FMEA, hazard analysis, and risk-control documentation.




Coordinate process, equipment, cleaning/clean-room and sterilization validation activities, including IQ/OQ/PQ where applicable.
Manage supplier qualification, supplier audits, incoming quality, and Supplier Corrective Action Requests (SCAR).
Investigate customer complaints, product non-conformities, deviations, and quality issues and perform root-cause analysis using tools such as 5 Why and Fishbone.
Maintain calibration and validation records and ensure equipment remains within approved status.
Support EU MDR 2017/745, CE Marking, CDSCO/Indian Medical Device Rules, and other applicable regulatory requirements.
Review product labelling, IFU, packaging, specifications, and quality documentation.
Support Post-Market Surveillance (PMS), complaint handling, vigilance, and PMCF activities where applicable.
Coordinate with R&D;, Production, QC, Regulatory Affairs, Engineering, and Supply Chain t

📌 Quality Analyst Vasai Virar (Vasai-Virar)
🏢 Aviyana Ventures
📍 Vasai-Virar