Key Responsibilities: We are looking for a detail-oriented and quality-focused professional to join our Quality Assurance team and support the implementation and maintenance of the Quality Management System (QMS) in compliance with ISO 13485:2016 requirements.

This role involves managing quality documentation, maintaining SOPs, supporting quality processes, and ensuring compliance with regulatory and quality standards applicable to medical devices and ophthalmic products. It is an excellent opportunity for candidates interested in Quality Assurance, Regulatory Compliance, and Quality Management Systems within the medical device industry.

Salary Package: ₹1.8 LPA – ₹3.0 LPA

Key Responsibilities:

1. Maintain and control Quality Management System (QMS) documents in accordance with ISO 13485:2016 requirements.

2. Prepare, review, and update Standard Operating Procedures (SOPs).

3. Handle CAPA (Corrective and Preventive Action) activities and maintain related documentation.

4. Manage Change Control documentation and associated records.

5. Plan, coordinate, and support Internal Audit activities.

6. Prepare, update, and maintain Device Master Files (DMF).

7. Ensure proper document control, record management, and data integrity.

8. Support quality compliance activities and continuous improvement initiatives.

9. Assist during external audits, regulatory inspections, and compliance reviews.

10. Ensure adherence to company quality procedures and applicable regulatory standards.