Q.A Executive
Job Summary
The Executive / Senior Executive – QA/RA will be responsible for supporting and maintaining quality systems and regulatory documentation for medical devices. The role involves preparation, review, and management of technical documentation in compliance with applicable regulatory requirements, including EU MDR.
Key Responsibilities
- Prepare, review, and maintain Device Master File (DMF) and Design Master File (DHF/DMF) documentation.
- Support ETO (Equipment/Engineering/Equipment Tooling/ETO) validation activities as applicable.
- Assist in product registration activities for domestic and international markets.
- Prepare and maintain EU MDR Technical Documentation / Technical File as per MDR (EU) 2017/745.
- Coordinate with cross-functional teams (R&D, Production, Regulatory, Design, and QC) to collect and verify technical data.
- Ensure compliance with ISO 13485, EU MDR, and applicable regulatory standards.
- Participate in internal audits, regulatory audits, and inspections.
- Maintain document control, change management, and version tracking.
- Support CAPA, risk management, and post-market documentation as required.
Should be aware about clean room validation activity.