QMS Research Associate

Location: Chennai

Position Type:

Reports To:

About the Role

Quality Management System (QMS)

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.