Medical Device Quality Manager

17 hours ago

Nashik, Maharashtra, India beBeeBiomedical Full time ₹ 10,00,000 - ₹ 20,00,000
Job Opportunity:

The role of a biomedical engineer involves implementing and supporting the deployment of quality management systems in healthcare settings. Key responsibilities include collaborating with medical device companies, conducting training sessions for healthcare professionals, providing clinical application support, and working closely with product and engineering teams.

Candidates are expected to have a strong background in biomedical engineering, relevant industry experience, and knowledge of compliance frameworks such as ISO 13485 and FDA 21 CFR Part 11.

Key Responsibilities:
  • Collaborate with medical device and healthcare companies to deploy quality management systems.
  • Conduct training sessions, workshops, and onboarding programs for healthcare professionals and client teams.
  • Act as a subject matter expert in compliance standards.
  • Provide clinical application support and liaise with hospitals, laboratories, and device manufacturers.
  • Support clients during audits, inspections, and compliance reviews.
Requirements:
  • Education: Bachelor's or Master's degree in Biomedical Engineering or related field.
  • Experience: Prior exposure to medical devices, hospital equipment, or clinical applications.
  • Knowledge of compliance frameworks: ISO 13485, FDA 21 CFR Part 11.
  • Ability to train, mentor, and support healthcare professionals with clarity.
  • Strong problem-solving mindset and ability to work with cross-functional teams.
  • Excellent communication & presentation skills.

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