We are looking for a detail-oriented QA professional 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 teams to resolve quality issues.

- Ensure proper traceability of raw materials, components, manufacturing processes, and finished medical devices.

These responsibilities reflect common medical-device QA requirements, particularly around ISO 13485 QMS, design controls, CAPA, validation, supplier quality, audits, and regulatory documentation.

Required Qualifications

- Bachelor's degree in Biomedical Engineering, Biotechnology, Pharmacy, Life Sciences, Mechanical/Electronics Engineering, Quality Engineering, or a related field.

- 2–5 years of experience in Quality Assurance within the Medical Device / MedTech industry.

- Solid working knowledge of ISO 13485:2016.

- Knowledge of ISO 14971, EU MDR 2017/745, CE Marking, and CDSCO/Indian Medical Device Rules.

- Practical experience with CAPA, NCR, Change Control, Risk Management, Validation, Document Control, and Audits.

- Experience in medical-device manufacturing and quality documentation will be preferred.

Preferred Skills

- ISO 13485 Internal Auditor / Lead Auditor certification.

- Knowledge of DHF, DMR, DHR, Technical File, GSPR, CER, PMS and PMCF.

- Knowledge of sterilization validation such as ETO/Gamma/Steam, where applicable.

- Good analytical, documentation, communication, and problem-solving skills.

- Strong attention to detail and ability to work with cross-functional teams.

Pay: Up to ₹40,000.00 per month

Work Location: In person

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