Sr. Director, Quality Leadership (QLT)
Core
Lead the total quality function for a plant or group of plants, ensuring compliance with global, local, and internal regulations and quality policies.
Role type
Sr. Director, Quality Leadership (Management)
Builds
Quality Management Systems, regulatory compliance, and product sterility systems for medical devices.
Domain
Medical Devices / Healthcare Manufacturing
Required skills
Quality Management Systems, Regulatory Affairs, SOP development, Budget management, Team leadership, Succession planning, Post-market surveillance, Sterility systems, Documentation control, Process improvement
Preferred skills
Pharmacy degree, Law/Medicine/Engineering degree, EU MDR experience, MDSAP certification support
Technologies
ISO 13485, ISO 14000, EU MDR, FDA QSR, MDD, MDSAP
Responsibilities
Manage and direct Quality Assurance Departments including Quality Systems, Documentation Control, Quality Control, Quality Engineering, Regulatory Affairs, Complaint Handling, and Laboratory Services; Ensure compliance with EU MDR, FDA QSRs, ISO 13485, and ISO 14000 standards; Implement systems to prevent product recalls and manage post market surveillance actions; Maintain responsibility for product sterility systems and product release; Identify potential successors for key positions and develop readiness plans; Identify future budgetary requirements and manage Quality Assurance budget within target.
Seniority
Senior, hands-on IC