Head of Design Quality Assurance (fmd)

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 Centerincluding 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 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
• High 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 employees
• Good and professional relationship to and communication with international colleagues and superiors
• Fluent in English and German both in written and spoken