Senior Medical Device Quality Assurance Specialist

6 hours ago


Mysore, Karnataka, India beBeeBiomedicalEngineer Full time ₹ 9,00,000 - ₹ 12,00,000
Job Description

We are seeking a highly skilled Biomedical Engineer to join our team. As an eQMS implementation specialist, you will be responsible for deploying quality management systems for medical device and healthcare companies.

  • Deploy eQMS for medical device and healthcare companies.
  • Conduct training sessions, workshops, and onboarding programs for healthcare professionals and client teams.
  • Act as a subject matter expert in compliance standards (ISO 13485).
  • Provide clinical application support and liaise with hospitals, laboratories, and device manufacturers.
  • Gather customer feedback and work closely with product & engineering teams to support feature improvements.
  • Support clients during audits, inspections, and compliance reviews.

Key Responsibilities:

  • Deploy eQMS solutions for medical device and healthcare companies.
  • Develop and deliver training programs for healthcare professionals.
  • Ensure compliance with regulatory standards (ISO 13485).
  • Collaborate with cross-functional teams to improve product features.
  • Provide technical support to clients during audits and inspections.

About the Role

This is an exciting opportunity to join a dynamic team of professionals who are passionate about delivering innovative solutions to the healthcare industry.

Requirements:

  • Bachelor's or Master's degree in Biomedical Engineering, Clinical Engineering, Biotechnology, or equivalent.
  • Prior experience working with medical devices, hospital equipment, or clinical applications.
  • Knowledge of compliance frameworks: ISO 13485, GxP (preferred).
  • Excellent communication and presentation skills.
  • Ability to work effectively in a team environment.

Skills and Qualifications:

  • Strong analytical and problem-solving skills.
  • Excellent documentation and communication skills.
  • Ability to adapt to changing priorities and deadlines.
  • Collaborative mindset and strong teamwork skills.


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