Biomedical Engineer – eQMS Implementation, Surat, INDIA Onsite

1 week ago

Surat, Gujarat, India Krtya Technologies Full time ₹ 8,00,000 - ₹ 12,00,000 per year

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 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.

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