Medical Device Compliance Engineer
3 weeks ago
GxPeople Global is seeking a Medical Device Compliance Engineer to join our team. In this role, you will be responsible for ensuring compliance to ISO 13485:2016 and/or Medical Device Single Audit Programme (MDSAP), FDA and other global requirements.
The ideal candidate will have experience in Medical Device Manufacturing, with a strong working knowledge of ISO 13485:2016, MDSAP, and Medical Devices Directive (93/42/EEC). They will also have Lead Auditor training and certification, as well as knowledge of IEC 60601 standards.
The salary for this position is estimated to be around $110,000 per year, based on industry standards and the level of experience required.
Key Responsibilities- Compliance to ISO 13485:2016 and/or Medical Device Single Audit Programme (MDSAP), FDA and other global requirements
- Plan and conduct internal and supplier audits, ideally as an ISO 13485:2016 Internal Auditor
- Co-host Notified Body, regulatory authority and customer audits (with QSM/SRAO)
GxPeople Global offers a comprehensive benefits package, including health insurance, retirement savings plan, and paid time off, as well as opportunities for professional growth and development.
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