Quality Assurance

1 week ago

Nalasopara Mumbai Maharashtra, India AMPA Orthodontics Private Limited Full time ₹ 3,00,000 - ₹ 3,60,000 per year

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

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: ₹25, ₹30,000.00 per month

Benefits:

  • Cell phone reimbursement
  • Health insurance
  • Provident Fund

Work Location: In person

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