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

Fresenius Medical Care North America; United States; Remote; USD 140,000 - 180,000; Full time

Job summary

A leading global healthcare company is seeking a Head of Design Quality Assurance to provide leadership across their Design Quality group. This role oversees compliance for a range of medical devices and ensures consistent application of design control processes globally. The ideal candidate will possess strong knowledge of regulations and quality management standards relevant to the medical sector and have experience managing cross-functional teams in a fast-paced environment.

Qualifications

• Minimum 5 years in R&D, regulatory affairs, or quality management for medical devices.
• Advanced knowledge of FDA regulations, EU MDR, ISO 13485.
• Fluent in English and German, both in written and spoken.

Responsibilities

• Provide global leadership to the DQA team for design quality assurance.
• Ensure compliance with design control processes and regulations.
• Promote continuous improvement and operational excellence.

Skills

Leadership

Quality Management

Regulatory Affairs

Problem Solving

Cross-Functional Collaboration

Education

Bachelor’s or Master’s degree in engineering or similar technical field

Job description

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 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
• 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