Vice President, Global Quality Assurance, Medical Devices & Surgery
Core
Lead global quality strategy, systems, and compliance for three medical device businesses from development through post-market use.
Role type
Executive VP, Global Quality Assurance (Medical Devices)
Builds
Scalable Quality Management Systems and a high-performing global Quality organization
Domain
Medical Devices & Surgery
Required skills
Global quality strategy, regulatory compliance (FDA, EU MDR, ISO 13485, ISO 14971), risk-based decision making, organizational leadership, cross-functional partnership, supply chain quality, product lifecycle management
Preferred skills
Master's degree in scientific/engineering/healthcare, advanced quality/regulatory credentials, global leadership across cultures, language capabilities
Technologies
FDA QSR, EU MDR, ISO 13485, ISO 14971
Responsibilities
Set global quality strategy and governance; lead quality across manufacturing, R&D, design, product, and supplier functions; advance scalable QMS; guide risk-based decisions and field actions; partner with regulators and business leaders; build and develop the global Quality organization
Seniority
Executive, strategic leadership & mentorship