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You shall ensure that all Quality System procedures are established under one system that implements the requirements of the FDA QSR, ISO 9001, ISO 13485, Medical Device Directive (MDD), and other national and international regulatory requirements, as may be established from time-to-time.
Ensures the CAPA and Internal audit systems are operating effectively and close out of corrective actions meets expected deadlines.
ISO 13485, Medical Devices and CAPA systems
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