eQMS Implementation Specialist – Medical Device Industry

1 week ago

Bengaluru, Karnataka, India beBeeBiomedical Full time ₹ 15,00,000 - ₹ 25,00,000

About Orcanos:

Orcanos is a global provider of eQMS (Electronic Quality Management System) and ALM (Application Lifecycle Management) solutions, helping medical device, pharma, and healthcare companies meet ISO 13485, ISO 14971, FDA 21 CFR Part 11, and other compliance standards.

Our platform enables clients to streamline compliance, risk management, documentation, training, and audits—all within a single collaborative environment.

Job Location: Surat, INDIA

Experience: 2-7 Years

What You'll Do

  • Collaborate with medical device and healthcare companies to deploy 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).

Key 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.

We Are Seeking A

A talented Biomedical Engineer with experience in eQMS implementation to join our team.

This role requires a highly skilled professional who can collaborate with medical device and healthcare companies to deploy our eQMS solution.

The ideal candidate will have prior experience in medical devices, hospital equipment, or clinical applications, and knowledge of compliance frameworks such as ISO 13485 and FDA 21 CFR Part 11.

We Offer

A competitive salary package and opportunities for growth and development.

Working with a global company that provides innovative solutions to the healthcare industry.

The chance to work with a diverse team of professionals who share your passion for improving healthcare outcomes.

Become an expert in eQMS implementation and contribute to the success of our clients.

We Are An Equal Opportunities Employer And Welcome Applications From All Qualified Candidates.

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