QMS Research Associate

Location : Chennai

Position Type : Full-Time

Reports To : CEO / COO / Head of Production

About the Role

The QMS Research Associate will support the implementation, maintenance, and continual improvement of the Quality Management System (QMS) in alignment with ISO 13485 , USFDA , and CDSCO regulatory requirements. The role involves documentation control, data tracking, quality audits, training coordination, and ensuring compliance across R&D and manufacturing teams.

1. QMS Documentation & Records

• Prepare, review, and maintain SOPs, Work Instructions, Forms, and Quality Manuals .
• Ensure timely document revisions and control through the Document Control System.
• Maintain accurate logs of training records, CAPA files, and internal quality documentation.

2. Compliance & Regulatory Support

3. Internal Audits & CAPA

4. Quality Data & Metrics

5. Training & Cross-Functional Support

6. Risk Management

Qualifications & Skills

Preferred Skills (Good to Have)