Manager, Global QMS

Responsible for HT quality plan, culture initiatives and monitoring of objectives and KPIs. Own the global QMS training strategy; develop minimal requirements for training, onboarding and refresher training for all HT employees, assign, and track mandatory compliance training to ensure organization-wide competency. Improve and harmonize QMS policies across global sites to ensure consistency in compliance. Oversee the lifecycle of controlled documentation and data integrity. Manage the Corrective and Preventive Action (CAPA) system to ensure systemic issues are identified and closed. Global assessments across sites and management of CAPAs.

Detailed Description

Quality Management System activities to assist in global harmonization implementation to ensure compliance to applicable medical device regulations per jurisdiction, guidance and standards.

Develop and provide training for all HT employees ensuring training and awareness compliance across the HT org...

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