eQMS Implementation Specialist

7 hours ago

Madurai, Tamil Nadu, India beBeeeQMS Full time ₹ 10,00,000 - ₹ 15,00,000

Job Title: eQMS Implementation Specialist

Orcanos is a global provider of Electronic Quality Management System (EQMS) and Application Lifecycle Management (ALM) solutions. Our platform enables clients to streamline compliance, risk management, documentation, training, and audits—all within a single collaborative environment.

We are seeking an experienced eQMS Implementation Specialist to collaborate with medical device and healthcare companies to deploy our EQMS solution.

  • Conduct training sessions, workshops, and onboarding programs for healthcare professionals and client teams.
  • Act as a subject matter expert in compliance standards, including ISO 13485 and 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.

Requirements:

  • Bachelor's or Master's degree in Biomedical Engineering, Clinical Engineering, Biotechnology, or equivalent.
  • 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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