Quality Assurance Executive

Position Title: Executive – Quality Assurance
Department: Quality & Regulatory AffairsLocation: [Andheri ] (Site Change then Nala Sopara)

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

Immediate joiners only apply

Job Type: Full-time

Pay: ₹300,000.00 - ₹420,000.00 per year

Benefits:

• Cell phone reimbursement
• Health insurance
• Provident Fund

Work Location: In person