The Head of Design Quality Assurance is responsible for global leadership and coordination of all Design Quality Assurance activities across the entire product portfolio of In Center
Job Summary
The Head of Design Quality Assurance is responsible for global leadership and coordination of all Design Quality Assurance activities across the entire product portfolio of In Center.
This role ensures consistent and compliant execution of design control processes supporting regulatory readiness, product safety, and quality by design.
The position acts as a critical interface between development, regulatory, manufacturing, and quality functions to ensure a harmonized and effective approach to design assurance globally.
Matching Summary
The Head of Design Quality Assurance is responsible for global leadership and coordination of all Design Quality Assurance activities across the entire product portfolio of In Center.
Skills & Requirements
Must-have
Design control process execution
Global team leadership
Regulatory compliance management
Design quality strategy implementation
Cross-functional collaboration
Quality management systems
Risk management standards knowledge
Nice-to-have
Continuous improvement culture
Lean process thinking
Operational excellence mindset
Proactive and solution-oriented approach
International communication skills
Key Requirements
Bachelor’s or master’s degree in engineering or related technical field
Minimum 5 years experience in R&D, regulatory affairs, or quality management
Advanced knowledge of FDA 21 CFR 820, EU MDR, ISO 13485, ISO 14971
Fluent in English and German
Experience with CAPA methodology
Knowledge of medical device regulations and standards