Head of Design Quality Assurance

Role Overview

• Provide global disciplinary and functional leadership to the DQA team, covering all product types (active, nonactive, digital) and all regions (US, Mexico, Europe, China)
• Define and implement the DQA strategy and operating model to ensure consistent execution across geographies and product categories
• Drive team development, including resource planning, capability building, competency mapping, and succession planning
• Ensure effective task distribution, resource alignment, and performance delivery across the global team
• Promote a culture of continuous improvement, lean process thinking, and operational excellence
• Represent the DQA function in global and local leadership meetings, quality committees, and cross-functional governance bodies
• Actively contribute to the Design Quality leadership team, collaborating on global strategy, process evolution, and functional alignment
• Lead the global design quality assurance strategy, ensuring integration across product lines, technologies, and regions
• Harmonize design quality processes across the organization, establishing a global framework for compliant and efficient design control
• Coordinate and ensure the implementation of design control activities across all product development and design change projects
• Oversee compliance with applicable regulations (e.g., FDA 21 CFR 820, EU MDR, ISO 13485, ISO 14971, IEC 62304) and internal design control SOPs
• Establish and maintain robust design quality processes and tools, including design reviews, phase gates, and documentation systems
• Monitor and ensure global consistency and high performance of design assurance execution, with clear ownership of deliverables in terms of quality, time, and cost
• Align with manufacturing and supplier quality teams to ensure smooth design transfer and product realization

Requirements

• Successfully completed bachelor’s or master’s degree in engineering or a similar technical field, such as medical technology or natural sciences
• Experience of minimum 5 years in research and development, regulatory affairs or quality management for medical devices or pharmaceuticals
• Advanced knowledge of medical device regulations (FDA 21 CFR 820, NMPA regulation, EU MDR 745/2017, MDSAP etc.)
• Advanced knowledge of applicable quality management and of risk management standards (e. g. ISO13485, ISO14971, ICH Q10, EU GMP, FDA 21 CDR §820.250, etc.)
• Knowledge of internal and external processes and structures and of the corporate quality management requirements
• Solid knowledge of CAPA methodology
• Knowledge of Medical Device field and application
• Fluent in English and German, both in written and spoken

Benefits

• health insurance
• retirement plans
• flexible work arrangements
• professional development