Medical Device Quality Assurance Professional

1 day ago


Kurnool, Andhra Pradesh, India beBeeCompliance Full time ₹ 9,00,000 - ₹ 12,00,000
Job Overview

This role focuses on ensuring the highest standards of quality and compliance in product development, manufacturing, and post-market activities.

  • Quality Management System (QMS): Develop and maintain a QMS that aligns with regulatory requirements, ensuring products meet quality, safety, and performance standards.
  • Regulatory Expertise: Stay up-to-date with global medical device regulations and standards, providing expertise to support market entry and ongoing compliance.
  • Documentation Control: Establish and maintain accurate documentation, including technical files, regulatory submissions, quality agreements, and internal procedures.
  • Design Control & Development Support: Collaborate with cross-functional teams to ensure QA/RA input is integrated into design and development activities, ensuring compliance from the outset.
  • Risk Management: Participate in risk management activities throughout the product life cycle to identify and mitigate potential hazards.
  • Post-Market Surveillance & Vigilance: Monitor device performance in the market, investigate customer complaints and non-conformity, and manage vigilance reporting.
  • Supplier Quality Management: Support the management of supplier quality and compliance.
  • Internal Audits & Process Improvement: Conduct internal audits and lead initiatives to improve processes and ensure adherence to QMS requirements.


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