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

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 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

Serve as a key contributor to regulatory readiness, innovation enablement, and the overall design quality maturity of the Business Unit

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

Your profile

Successfully completed bachelors or masters 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