Quality Assurance Manager
3 weeks ago
We are seeking a highly skilled Quality Assurance Manager to join our team at GxPeople Global. This role involves taking full ownership of the Quality Management System (QMS) and supporting the QA/RA team with issues related to quality assurance, control, and compliance.
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 $120,000 per year, based on industry standards and the level of experience required.
Key Responsibilities- Support quality driven technology driven projects
- Development and update of QMS procedures and associated Work Instructions and documentation
- Compliance to ISO 13485:2016 and/or Medical Device Single Audit Programme (MDSAP), FDA and other global requirements
- Experience and working knowledge of Quality Assurance
- Experience in Medical Device Manufacturing
- Lead Auditor trained and certified
GxPeople Global offers a comprehensive benefits package, including health insurance, retirement savings plan, and paid time off.
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