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

• Support compliance with ISO 13485, ISO 14971 (Risk Management) , and relevant medical device regulations.
• Assist with USFDA and CDSCO audits , submissions, and documentation readiness.
• Track regulatory requirements and ensure QMS updates as needed.

3. Internal Audits & CAPA

• Assist in planning and conducting internal audits for various departments.
• Coordinate creation, closure, and verification of CAPA , NCR , and deviation reports .
• Follow up with teams to ensure timely corrective actions.

4. Quality Data & Metrics

• Track quality KPIs such as
• NCR trends
• Calibration schedules
• Training compliance
• Audit findings
• Support management review meetings with data summaries and reports.

5. Training & Cross-Functional Support

• Coordinate QMS-related training for employees (SOP training, audits, safety, etc.).
• Collaborate with R&D, Manufacturing, and Operations teams to ensure QMS adherence.
• Help new employees understand QMS processes (induction).

6. Risk Management

• Assist in updating Risk Management Files (RMF) for products.
• Support FMEA reviews, hazard identification, and design risk assessments.

Qualifications & Skills

• Bachelor’s/Master’s in Biotechnology, Biomedical Engineering, Microbiology, Life Sciences or related field.
• 1–3 years of experience in QMS, QA, or regulatory domain (Medical Devices preferred).
• Knowledge of ISO 13485, ISO 14971 , and medical device regulations .
• Strong documentation and organisational skills.
• Ability to work cross-functionally and follow structured procedures.
• Excellent communication skills and attention to detail.

Preferred Skills (Good to Have)

• Experience in internal audits (ISO 13485).
• Exposure to design & development processes in regulated environments.
• Hands-on experience with QMS software or document control systems.
• Knowledge of GMP and manufacturing workflows.