Head of Design Quality Assurance (f/m/d)
Core
Global leadership of Design Quality Assurance (DQA) for active, nonactive, and digital medical/non-medical devices, ensuring compliant design control processes and regulatory readiness.
Role type
Senior leadership (Head of DQA)
Builds
Global design quality assurance strategy and operating model for medical device portfolios
Domain
Medical device industry / Regulatory Quality Management
Deliverable
client delivery
Required skills
Disciplinary and functional leadership, global strategy definition, team development and succession planning, cross-functional governance, regulatory compliance (FDA, EU MDR, ISO 13485), risk management, CAPA methodology, design control process design
Preferred skills
Lean process thinking, operational excellence, innovation enablement
Technologies
Design review tools, phase gate systems, documentation systems
Responsibilities
Provide global disciplinary and functional leadership to the DQA team, Define and implement the DQA strategy and operating model, Drive team development and resource planning, Represent the DQA function in global leadership meetings, Harmonize design quality processes across the organization, Oversee compliance with applicable regulations and internal SOPs, Coordinate implementation of design control activities across product development projects
Seniority
Senior, hands-on IC with strategic scope
