Teamleiter (w/m/d) Quality Management Validation
Core
Leading the Quality Management Validation team to plan, control, and oversee qualification and validation activities for processes, equipment, and machines in a medical device manufacturing environment.
Role type
Team Lead, Quality Management Validation
Builds
Validated processes, equipment, and machines for medical device production
Domain
Medical Devices / Quality Management / Validation
Required skills
Team leadership, Validation and Qualification of processes/equipment, Regulatory compliance (EU MDR, ISO 13485, QMSR), Audit management, Cross-functional collaboration
Preferred skills
Engineering or Natural Sciences degree, Experience in regulatory affairs, German and English fluency
Technologies
EU MDR, ISO 13485, QMSR
Responsibilities
Lead and develop the Validation team, Plan and execute qualification and validation activities, Ensure compliance with regulatory requirements, Act as contact for internal/external audits, Collaborate with Production, R&D, and Regulatory Affairs, Drive process development and implementation
Seniority
Senior, Hands-on IC with team leadership