QA Manager
Cambridge, England, United Kingdom
CAPU Search
MDSAP quality system and CE certification. Represent the company during audits by its Notified Body or other organisations Lead the QMS integration activities with Hologic Oversee and manage document control in regard to global Quality standards regulations and other requirements. ensure compliance for the internal quality system and provide suitable interpretation to directors, managers and staff within the organisation … Oversee the change control process ensuring that it maintains the requirement of ISO 13485; and all other relevant regulatory requirements within the quality system. Oversee the CAPA and internal/external audit processes Prepare quality documentation as required for other worldwide territories eg FDA, TGA etc to support submission. Manage customer tracking as it relates to quality of More ❯
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