Senior Quality Assurance Professional

2 weeks ago


Erode, Tamil Nadu, India beBeeQuality Full time ₹ 8,00,000 - ₹ 15,00,000
Job Description

We are seeking a seasoned Quality Assurance Specialist to join our team. As a key member of our organization, you will be responsible for implementing and maintaining a comprehensive Quality Management System (QMS) that ensures our products meet the highest standards of quality, safety, and regulatory compliance.

  • Regulatory Compliance: Ensure adherence to relevant medical device regulations for market entry and ongoing compliance.
  • Documentation Management: Develop, review, and control technical files, regulatory submissions, and internal procedures.
  • Design Control & Development Support: Provide QA/RA input and support for design and development activities to ensure 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 manage vigilance reporting.
  • Supplier 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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