Medical Device Quality Assurance Specialist

23 hours ago


Vellore, Tamil Nadu, India beBeeCompliance Full time ₹ 12,50,000 - ₹ 17,50,000

As a Compliance Specialist, you will play a crucial role in helping medical device and healthcare companies meet ISO 13485 and FDA 21 CFR Part 11 standards.

You will collaborate with clients to deploy our eQMS solution, conduct training sessions, and provide clinical application support.

We are looking for an experienced professional with a degree in Biomedical Engineering or a related field.

You will have prior exposure to medical devices, hospital equipment, or clinical applications, and knowledge of compliance frameworks such as ISO 13485 and FDA 21 CFR Part 11.

Key responsibilities include:

  • Deploying eQMS solutions to medical device and healthcare companies
  • Conducting training sessions and workshops for healthcare professionals
  • Providing clinical application support and liaising with hospitals, laboratories, and device manufacturers
  • Gathering customer feedback and working closely with product & engineering teams to support feature improvements

We offer a dynamic work environment with opportunities for growth and development. If you are passionate about compliance and quality management, we encourage you to apply.

The ideal candidate will possess excellent communication and presentation skills, as well as a strong problem-solving mindset and ability to work with cross-functional teams.

Requirements:

  • Bachelor's or Master's degree in Biomedical Engineering or a related field
  • Prior experience in medical devices, hospital equipment, or clinical applications
  • Knowledge of compliance frameworks: ISO 13485, FDA 21 CFR Part 11
  • Excellent communication and presentation skills
  • Strong problem-solving mindset and ability to work with cross-functional teams

Benefits:

  • Dynamic work environment
  • Opportunities for growth and development


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