
Quality Management Professional
17 hours ago
Electronic Quality Management Specialist
">We are seeking a skilled Electronic Quality Management Specialist to join our team. As an expert in quality management systems, you will collaborate with medical device and healthcare companies to deploy our eQMS solution.
">Key responsibilities include:
">- ">
- Conducting training sessions, workshops, and onboarding programs for healthcare professionals and client teams.">
- Acting as a subject matter expert in compliance standards (ISO 13485, FDA 21 CFR Part 11).">
- Providing clinical application support and liaising with hospitals, laboratories, and device manufacturers.">
- Gathering customer feedback and working closely with product & engineering teams to support feature improvements.">
- Supporting clients during audits, inspections, and compliance reviews.">
Required skills and qualifications include:
">- ">
- 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).">
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