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.
- Strong 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
