eQMS Implementation Specialist

1 week ago


Malappuram, Kerala, India beBeeBiomedical Full time ₹ 15,93,120 - ₹ 20,90,400
Job Title

Biomedical Engineer - eQMS Implementation

About Us

Orcanos provides eQMS and ALM solutions to medical device, pharma, and healthcare companies.

What We Do
  • Deploy eQMS for medical device and healthcare companies.
  • Conduct training sessions, workshops, and onboarding programs.
  • Act as a subject matter expert in compliance standards.
  • Provide clinical application support and liaison with hospitals, laboratories, and device manufacturers.
  • Gather customer feedback and work closely with product & engineering teams.
  • Support clients during audits, inspections, and compliance reviews.
Requirements
  • Education: Bachelor's or Master's degree in Biomedical Engineering, Clinical Engineering, Biotechnology, or equivalent.
  • Experience: Prior exposure to medical devices, hospital equipment, or clinical applications.
  • Knowledge of compliance frameworks: ISO 13485, FDA 21 CFR Part 11, GxP, MDR (preferred).
  • 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.
Soft Skills
  • Analytical and detail-oriented with strong documentation skills.
  • Empathy and patience while supporting clinical staff and clients.
  • Collaborative mindset to work with diverse stakeholders.
  • Adaptability to handle regulatory challenges and evolving customer needs.
Language Requirements
  • Fluency in English (written & spoken) is mandatory.


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