Quality Management System Coordinator

2 days ago


Vizag, Andhra Pradesh, India beBeeRegulation Full time ₹ 9,00,000 - ₹ 15,00,000
Job Title: Quality Management System Coordinator

About the Role:

  • We are seeking a highly skilled Quality Management System Coordinator to ensure our products meet quality, safety, and regulatory standards.
  • The successful candidate will be responsible for implementing and maintaining a QMS that adheres to relevant medical device regulations.
  • This role involves managing technical files, regulatory submissions, quality agreements, and internal procedures.
  • You will provide QA/RA input and support for design and development activities to ensure compliance from the outset.
  • Additionally, you will participate in risk management activities throughout the product life cycle to identify and mitigate potential hazards.
  • Monitor device performance in the market, investigate customer complaints and non-conformity, and manage vigilance reporting.
  • Support the management of supplier quality and compliance.
  • Conduct internal audits and lead initiatives to improve processes and ensure adherence to QMS requirements.

Key Qualifications & Skills:

  • Deep knowledge of global medical device regulations and standards.
  • Excellent problem-solving and attention to detail.
  • Strong communication skills to coordinate with internal departments and external stakeholders.
  • Bachelor's Degree in a relevant field such as engineering, life sciences, or a related technical discipline.
  • Previous experience in QA/RA within the medical device industry is an advantage.


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