Job Description

Job Responsibilities:

1. Quality Management System (QMS)

·        Establish, implement, maintain, and continuously improve the Quality Management System (QMS) in compliance with:

o   ISO 13485

o   ISO 14971

o   FDA 21 CFR Part 820 / QMSR

o   MDSAP requirements

o   EU MDR requirements (where applicable)

o   Customer-specific requirements

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