Head of Design Quality Assurance (f/m/d)

In this role you lead the global Design Quality Assurance function across all product types and regions to ensure compliant design control throughout development and change projects. You drive strategy, governance, and capability-building to support regulatory readiness, product safety, and quality by design. You collaborate with regulatory, manufacturing, and development teams to harmonize processes and systems on a worldwide scale. This position offers impact by shaping design assurance maturity and enabling cross-functional execution aligned with corporate quality goals. You will guide a distributed team to deliver high-quality design outputs that meet global standards.

• Provide global disciplinary and functional leadership to the DQA team across regions and product categories
• Define and implement the DQA strategy and operating model for consistent geographies-wide execution
• Drive team development, including resource planning, competency mapping, and succession planning
• Ensure effective task distribution, resource alignment, and performance delivery worldwide
• Promote continuous improvement, lean thinking, and operational excellence
• Represent DQA in leadership meetings, quality committees, and governance bodies
• Contribute to global Design Quality strategy and cross-functional alignment
• Harmonize design quality processes and establish a global design control framework
• Coordinate design control activities in all development and design change projects
• Ensure compliance with regulatory requirements (FDA 21 CFR 820, EU MDR, ISO 13485, ISO 14971, IEC 62304) and internal SOPs
• Establish and maintain robust design quality processes and tools (design reviews, phase gates, documentation systems)
• Monitor global performance and ensure clear ownership of quality, time, and cost
• Align with manufacturing and supplier quality teams for smooth design transfer and product realization

• Bachelor’s or Master’s degree in engineering or similar technical field
• Minimum 5 years in R&D, regulatory affairs, or quality management for medical devices or pharmaceuticals
• Advanced knowledge of medical device regulations (FDA 21 CFR 820, NMPA, EU MDR 745/2017, MDSAP)
• Advanced knowledge of quality management and risk management standards (ISO 13485, ISO 14971, ICH Q10, EU GMP, FDA 21 CFR §820.250)
• Knowledge of internal/external quality processes and corporate quality requirements
• Solid knowledge of CAPA methodology
• Knowledge of Medical Device field and application
• High engagement, proactive and solution-oriented, cross-functional collaboration
• Fluent in English and German

• high engagement and target-oriented
• proactive and solution-focused
• strong cross-functional collaboration
• design control
• CAPA
• regulatory compliance (medical devices)