
eQMS Implementation Specialist
1 week ago
Biomedical Engineer - eQMS Implementation
About UsOrcanos provides eQMS and ALM solutions to medical device, pharma, and healthcare companies.
What We Do- Deploy eQMS for medical device and healthcare companies.
- Conduct training sessions, workshops, and onboarding programs.
- Act as a subject matter expert in compliance standards.
- Provide clinical application support and liaison with hospitals, laboratories, and device manufacturers.
- Gather customer feedback and work closely with product & engineering teams.
- Support clients during audits, inspections, and compliance reviews.
- 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.
- 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.
- Fluency in English (written & spoken) is mandatory.
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