Director of Quality and Compliance
Core
Lead the Image Guided Therapy Devices quality systems team, ensuring QMS compliance with FDA/Notified body regulations and driving harmonization across global sites.
Role type
Director of Quality and Compliance
Builds
Global quality management systems for medical imaging devices
Domain
Medical device manufacturing / Regulatory compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Strategic leadership of quality teams, QMS implementation and simplification, CAPA and change management, internal/external audit execution, KPI monitoring, business process management, knowledge of FDA/ISO13485/ISO14971/EUMDR regulations
Preferred skills
Master's degree in business/management/quality, experience in multi-national matrix organizations
Technologies
FDA regulations, ISO13485, ISO14971, EUMDR
Responsibilities
Lead and develop the IGTD quality systems team, ensure effective operation of the QMS, advise senior leadership on quality strategy, enforce harmonization of quality systems across sites, act as quality representative on the Business Category Leadership Team
Seniority
Director, strategic leadership