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Quality Systems Analyst
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$80,000 - $90,000 a year
Full-time
- The Quality Systems Analyst/Auditor is responsible for ensuring that the Quality Management System (QMS) for our medical devices meets the required standards of regulatory bodies, both domestic and international.
- This role encompasses internal audit activities, external standards management, CAPA ownership and support, label management, and gap assessments related to global medical device regulations.
- Track, analyze, and communicate changes to external standards that impact the medical device QMS.
- Support other CAPA owners in the identification of root causes, implementation of corrective actions, and verification of effectiveness.
- Continuously assess the QMS against global medical device regulations.
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