Biomedical Engineer – eQMS Implementation, Surat, INDIA Onsite

About Orcanos:

Orcanos is a global provider of eQMS (Electronic Quality Management System) and ALM (Application Lifecycle Management)

compliance, risk management, documentation, training, and audits

Job Location

Experience: 2-7 Years

What You’ll Do

• Collaborate with

  medical device and healthcare companies

  to deploy Orcanos eQMS.
• Conduct

  training sessions, workshops, and onboarding programs

  for healthcare professionals and client teams.
• Act as a

  subject matter expert

  in compliance standards (ISO 13485, FDA 21 CFR Part 11).
• 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

  .

What You’ll Bring

• 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

  (to engage medical professionals and regulatory staff).

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.