Senior Medical Device Quality Assurance Specialist

13 hours ago

Udaipur, Rajasthan, India beBeeCompliance Full time ₹ 15,00,000 - ₹ 25,00,000
Senior Medical Device Quality Assurance Specialist

We are seeking an experienced Senior Medical Device Quality Assurance Specialist to join our esteemed organization in the medical industry. The ideal candidate will possess strong knowledge of quality systems and regulatory frameworks for medical devices, with a minimum of 5-7 years of experience in ensuring compliance with regulatory requirements.

Responsibilities:

  • Ensure compliance with ISO 13485, MDD, MDR, GMP, GDP, and QMS standards by conducting regular audits and inspections.
  • Develop and implement effective risk management strategies to mitigate potential risks associated with medical devices.
  • Coordinate with local authorities to obtain necessary permissions and approvals for medical device submissions.
  • Manage and maintain accurate records of CAPA (Corrective and Preventive Actions) and ensure timely implementation of actions to maintain compliance.
  • Support audits, inspections, and ensure readiness for regulatory authority reviews by maintaining accurate documentation and records.

Candidate Profile:

  • Strong understanding of quality systems and regulatory frameworks for medical devices.
  • Hands-on experience with regulatory submissions, post-market surveillance, and risk management.
  • Excellent knowledge of GMP, GDP, and ISO 13485 standards.
  • Strong communication, documentation, and coordination skills.

Key Skills:

  • Regulatory Compliance: Knowledge of ISO 13485, MDD, MDR, GMP, GDP, and QMS standards.
  • Risk Management: Experience in developing and implementing effective risk management strategies.
  • Communication: Excellent written and verbal communication skills.
  • Documentation: Strong documentation and record-keeping skills.

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