Medical Device Quality Assurance Specialist

2 weeks ago


Navi Mumbai Mumbai City Mumbai, India beBeeCompliance Full time ₹ 1,50,00,000 - ₹ 2,00,00,000
Medical Devices Assessor/Auditor Job Opportunity

This role plays a critical part in guaranteeing the quality and conformity of medical devices with regulatory standards.

Key Responsibilities:
  1. Plan and execute audits to ensure compliance with ISO 13485, EU MDR, and MDSAP standards.
  2. Examine and assess technical files and documentation for medical devices.
  3. Collaborate with audit teams to ensure quality, conformity, and client satisfaction.
  4. Support certification decisions and regulatory reviews as per DNV and accreditation guidelines.
Role Requirements:

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