Biomedical eQMS Specialist

4 days ago

Vadodara, Gujarat, India beBeeCompliance Full time ₹ 8,00,000 - ₹ 10,00,000

About our eQMS Implementation Job:

Orcanos is a global provider of Electronic Quality Management Systems and Application Lifecycle Management solutions, assisting medical device, pharmaceutical, and healthcare companies in meeting compliance standards.

We offer a collaborative environment that streamlines compliance, risk management, documentation, training, and audits.

The job location is Surat, INDIA.

This is an entry-level position for 2-7 years of experience.

Job Responsibilities
  • Deploy eQMS systems to medical device and healthcare companies.
  • Provide training sessions, workshops, and onboarding programs for healthcare professionals and client teams.
  • Act as a subject matter expert in compliance standards.
  • Offer clinical application support and liaise with hospitals, laboratories, and device manufacturers.
  • Gather customer feedback and collaborate with product and engineering teams to enhance features.
  • Support clients during audits, inspections, and compliance reviews.
Required Skills and Qualifications
  • Educational background: Bachelor's or Master's degree in Biomedical Engineering, Clinical Engineering, Biotechnology, or equivalent.
  • Prior exposure to medical devices, hospital equipment, or clinical applications.
  • Familiarity with compliance frameworks: ISO 13485, FDA 21 CFR Part 11, GxP, MDR (desired).
  • Ability to train, mentor, and support healthcare professionals with clarity.
  • Strong problem-solving mindset and ability to work with cross-functional teams.
  • Excellent communication and presentation skills.
Benefits
  • Analytical and detail-oriented approach 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 and spoken) is mandatory.

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