In your role as Head of Design Quality Assurance (f/m/d) you will be responsible for disciplinary and functional leadership of the Design Quality Assurance (DQA) group within the SQR – In Center Product Quality & CE Supplier Quality – Design Quality Department.

The Head of Design Quality Assurance (DQA) is responsible for the global leadership and coordination of all Design Quality Assurance activities across the entire product portfolio of In Center—including active, nonactive, and digital medical, digital non-medical devices. This role ensures consistent and compliant execution of design control processes for all development and change projects, supporting regulatory readiness, product safety, and quality by design.

The role combines disciplinary leadership, functional strategy, and hands-on expert guidance, overseeing a globally distributed team across the US, Mexico, Europe, and China. The position acts as a critical interface between development, regulatory, manufacturing, and quality functions, ensuring a harmonized and effective approach to design assurance on a global scale.

Your tasks

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 categoriesDrive team development, including resource planning, capability building, competency mapping, and succession planningEnsure effective task distribution, resource alignment, and performance delivery across the global teamPromote a culture of continuous improvement, lean process thinking, and operational excellenceRepresent the DQA function in global and local leadership meetings, quality committees, and cross-functional governance bodiesActively contribute to the Design Quality leadership team, collaborating on global strategy, process evolution, and functional alignmentLead the global design quality assurance strategy, ensuring integration across product lines, technologies, and regionsHarmonize design quality processes across the organization, establishing a global framework for compliant and efficient design controlServe as a key contributor to regulatory readiness, innovation enablement, and the overall design quality maturity of the Business UnitCoordinate and ensure the implementation of design control activities across all product development and design change projectsOversee compliance with applicable regulations (e.g., FDA 21 CFR 820, EU MDR, ISO 13485, ISO 14971, IEC 62304) and internal design control SOPsEstablish and maintain robust design quality processes and tools, including design reviews, phase gates, and documentation systemsMonitor and ensure global consistency and high performance of design assurance execution, with clear ownership of deliverables in terms of quality, time, and costAlign with manufacturing and supplier quality teams to ensure smooth design transfer and product realization

Your profile

Successfully completed bachelor’s or master’s degree in engineering or a similar technical field, such as medical technology or natural sciencesExperience of minimum 5 years in research and development, regulatory affairs or quality management for medical devices or pharmaceuticalsAdvanced 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 requirementsSolid knowledge of CAPA methodologyKnowledge of Medical Device field and applicationHigh engagement on achieving the targets and on the objectives of the position, proactive and solution-oriented approach towards problems, ability to work cross functional with all levels of employeesGood and professional relationship to and communication with international colleagues and superiorsFluent in English and German, both in written and spoken