- Maintain and improve the Quality Management System in accordance with ISO 13485 and applicable regulatory requirements.
- Ensure implementation and effectiveness of SOPs, quality plans, validation protocols, and change control processes.
- Review and approve deviations, CAPA, non-conformances, customer complaints, and risk management activities.
- Monitor quality metrics and drive continual improvement initiatives.
- Support supplier qualification, incoming quality control, in-process controls, and final release activities.
- Ensure readiness for internal, customer, certification, and regulatory audits.

Experience:

- 10-15 years of experience in Quality Assurance and/or Regulatory Affairs within the medical device industry.
- Experience with sterile disposable medical devices is preferred.
- Hands-on exposure to ISO 13485, CE/EU MDR, risk management, validation, and regulatory documentation is desirable.

Pay: ₹60,000.00 - ₹90,000.00 per month

Benefits:

- Adaptable schedule
- Health insurance
- Leave encashment
- Life insurance

Work Location: In person

📌 Senior Quality Analyst (India)
🏢 Iscon Surgicals
📍 India