eQMS Implementation Specialist

1 day ago

Nagpur, Maharashtra, India beBeeImplementation Full time ₹ 10,00,000 - ₹ 15,00,000
Implementation Specialist - eQMS, Surat

Orcanos provides Electronic Quality Management System and ALM solutions for medical device, pharma, and healthcare companies to meet compliance standards.

  • Key Responsibilities:
  • Deploy eQMS in collaboration with medical device and healthcare companies.
  • Conduct training sessions, workshops, and onboarding programs.
  • Act as a subject matter expert in compliance standards (ISO 13485, FDA 21 CFR Part 11).
  • Provide clinical application support and liaison services.
  • Gather customer feedback and work closely with product & engineering teams.
  • Support clients during audits, inspections, and compliance reviews.

Requirements:

  • Bachelor's or Master's degree in Biomedical Engineering, Clinical Engineering, Biotechnology, or equivalent.
  • Prior experience in medical devices, hospital equipment, or clinical applications.
  • Knowledge of compliance frameworks: ISO 13485, FDA 21 CFR Part 11, GxP, MDR (preferred).
  • Strong problem-solving mindset and ability to work with cross-functional teams.
  • Excellent communication & presentation skills.

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.

Language Requirements:

  • Fluency in English (written & spoken) is mandatory.

Benefits:

  • Opportunity to streamline compliance, risk management, documentation, training, and audits within a single environment.
  • Chance to work with a global provider of eQMS and ALM solutions.

Other Opportunities:

  • Professional growth and development through continuous learning and training.

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