Quality Analyst

Key Responsibilities:

· - Support implementation and maintenance of the Quality Management System (QMS) in compliance with ISO 13485:2016, MDR 2017, and applicable medical device regulations.

· - Prepare, review, and control quality documents (SOPs, Work Instructions, Policies).

· - Conduct internal audits, CAPA management, and change control activities.

· - Monitor adherence to Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP).

· - Assist in regulatory submissions and inspections (CDSCO, US FDA, SFDA, etc.).

· - Ensure training compliance and support cross-functional teams in QMS implementation.

· - Prepare and issue quality reports, NCR documentation, and audit records.

Qualifications & Experience:

· - B.Sc./M.Sc. in Biotechnology, Microbiology, Life Sciences, or related discipline.

· - Minimum 1 year of experience in QA (medical device industry preferred).

· - Knowledge of ISO 13485, MDR 2017, GMP/GDP.

· - Strong documentation, communication, and analytical skills.

Key Skills:

· - Quality Management Systems (QMS)

· - Internal Auditing (ISO 13485)

· - Regulatory & compliance awareness (Medical Devices)

- Documentation & reporting

Job Type: Full-time

Pay: ₹160,000.00 - ₹300,000.00 per year

Benefits:

• Cell phone reimbursement
• Health insurance
• Provident Fund

Work Location: In person