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

📍 Job Overview

Job Title: Head of Design Quality Assurance (f/m/d)

Company: Fresenius Medical Care

Location: Bad Homburg, Germany / Schweinfurt, Germany

Job Type: FULL_TIME

Category: Quality Assurance / Regulatory Affairs (Medical Devices)

Date Posted: December 09, 2025

Experience Level: 5-10 Years

Remote Status: On-site

🚀 Role Summary

• This senior leadership role is pivotal in establishing and executing the global Design Quality Assurance (DQA) strategy for Fresenius Medical Care's In Center product portfolio, encompassing active, non-active, and digital medical and non-medical devices.

• The Head of DQA will provide disciplinary and functional leadership to a globally distributed team, ensuring consistent and compliant design control processes across all development and change projects.

• A key focus will be on driving operational excellence, promoting a culture of continuous improvement, and ensuring regulatory readiness for product safety and quality by design.

• This position requires a strategic thinker with advanced knowledge of medical device regulations and quality management systems to harmonize global DQA operations and facilitate innovation.

📝 Enhancement Note: The "Head of Design Quality Assurance (f/m/d)" title, combined with the description emphasizing global leadership, cross-functional collaboration with R&D, regulatory, and manufacturing, and the specific mention of medical device regulations, strongly indicates a senior-level position within the Quality Assurance and Regulatory Affairs domain, specifically focused on the product development lifecycle. The "f/m/d" (female/male/diverse) is a common German job posting convention. The provided locations in Germany suggest an on-site requirement.

📈 Primary Responsibilities

• Lead and manage the global Design Quality Assurance (DQA) team, providing disciplinary and functional oversight across US, Mexico, Europe, and China, with responsibility for all product types (active, non-active, digital).

• Develop, implement, and refine the DQA strategy and operating model to ensure consistent, compliant, and efficient design control execution across all geographies and product categories.

• Drive team development initiatives, including strategic resource planning, capability building, competency mapping, performance management, and succession planning for the DQA function.

• Ensure effective task distribution, resource alignment, and consistent high performance delivery across the global DQA team, with clear ownership of quality, time, and cost for deliverables.

• Champion a culture of continuous improvement, lean process thinking, and operational excellence within the DQA team and across cross-functional development partners.

• Represent the DQA function in global and local leadership meetings, quality committees, and relevant governance bodies, acting as a key contributor to the Design Quality leadership team's strategic initiatives.

• Harmonize design quality processes organization-wide, establishing a global framework for compliant and efficient design control that integrates across product lines, technologies, and regions.

• Oversee and ensure the implementation of robust design control activities for all product development and design change projects, including design reviews, phase gates, and documentation systems.

• Ensure global compliance with applicable medical device regulations (e.g., FDA 21 CFR 820, EU MDR, ISO 13485, ISO 14971, IEC 62304) and internal design control Standard Operating Procedures (SOPs).

• Act as a key contributor to regulatory readiness, innovation enablement, and the overall design quality maturity of the Business Unit, aligning with manufacturing and supplier quality teams for seamless design transfer and product realization.

📝 Enhancement Note: The responsibilities listed are characteristic of a senior leadership role in a regulated industry like medical devices. The emphasis on global strategy, team leadership, process harmonization, and compliance with specific regulations (FDA, EU MDR, ISO) points to a strategic and operational management function, not just an individual contributor role.

🎓 Skills & Qualifications

Education:

Experience:

• Minimum of 5 years of progressive experience in Research & Development (R&D), Regulatory Affairs, or Quality Management within the medical device or pharmaceutical industry.

Required Skills:

• Advanced knowledge of global medical device regulations, including FDA 21 CFR 820, EU Medical Device Regulation (MDR 745/2017), NMPA regulations, and MDSAP.

• Advanced knowledge of applicable Quality Management Systems (QMS) standards such as ISO 13485 and risk management standards like ISO 14971.

• Solid understanding of internal and external processes, corporate quality management requirements, and a strong grasp of CAPA (Corrective and Preventive Action) methodology.

• Proven ability to work cross-functionally with employees at all levels and a proactive, solution-oriented approach to problem-solving.

• Excellent relationship-building and communication skills for effective collaboration with international colleagues and superiors.

Preferred Skills:

• Experience with digital medical devices and associated software lifecycle processes (e.g., IEC 62304).

• Familiarity with other relevant quality management standards (e.g., ICH Q10, EU GMP).

• Experience in implementing lean process thinking and driving continuous improvement initiatives.

• Demonstrated ability to define and implement strategic operating models and drive team development.

📝 Enhancement Note: The requirement for 'minimum 5 years' experience, coupled with the leadership responsibilities and advanced regulatory knowledge, places this role at a senior or managerial level within the Quality Assurance and Regulatory Affairs domain. The specific mention of various global regulations and standards (FDA, EU MDR, ISO 13485, ISO 14971) is critical for candidates in this field. Fluency in both English and German is a key requirement due to the specified locations and global scope.

📊 Process & Systems Portfolio Requirements

Portfolio Essentials:

• Demonstrate a track record of successfully implementing and managing robust Design Quality Assurance processes within a regulated environment, ideally medical devices.

• Provide examples of contributions to process optimization, specifically within design control, risk management, or quality management systems, showcasing efficiency gains or improved compliance.

• Showcase experience with system implementation or enhancement related to quality management, document control, or design tracking tools.

Process Documentation:

• Evidence of developing, implementing, or refining Standard Operating Procedures (SOPs) for design control, design reviews, phase gates, or risk management activities.

• Experience in establishing and maintaining comprehensive documentation systems that ensure traceability and compliance throughout the product lifecycle.

• Ability to articulate how processes were monitored, measured, and improved based on performance analysis and feedback loops.

📝 Enhancement Note: For a Head of Design Quality Assurance role, a portfolio would typically showcase strategic leadership, process development, and successful implementation of quality systems in a regulated environment. The emphasis is on demonstrating the ability to manage complex processes, ensure compliance, and drive continuous improvement at a strategic level, rather than just individual task execution.

💵 Compensation & Benefits

Salary Range:

Benefits:

• Comprehensive health insurance and occupational disability coverage.

• Generous paid time off, including vacation days and public holidays.

• Company pension scheme and other retirement savings options.

• Opportunities for professional development, including training, conferences, and certifications.

• Potential for performance-based bonuses and long-term incentive plans.

• Employee assistance programs and wellness initiatives.

Working Hours:

• Standard full-time work week is typically 40 hours, with flexibility often available to accommodate global team coordination and critical project needs.

📝 Enhancement Note: Salary estimates for leadership roles in Germany are typically based on industry averages for the specific sector (medical devices), experience level (5-10+ years in leadership), and location. Benefits are standard for large, established international companies like Fresenius Medical Care. The working hours are standard, but leadership roles often involve some flexibility.

🎯 Team & Company Context

🏢 Company Culture

Industry: Medical Technology / Healthcare. Fresenius Medical Care is a leading global provider of products and services for individuals with renal diseases, dialysis, and chronic/acute organ failure. This highly regulated industry demands stringent quality standards, innovation, and patient safety as core tenets.

Company Size: Large Enterprise (likely 100,000+ employees globally based on public information). This size implies robust processes, established global structures, and significant resources, but also potentially a more layered decision-making process.

Founded: 1912 (as Fresenius AG, with Fresenius Medical Care established later). This long history signifies stability, deep industry expertise, and a well-established market presence.

Team Structure:

• The DQA team is global and distributed across multiple continents (US, Mexico, Europe, China), indicating a need for strong remote leadership and cross-cultural communication skills.

• The role reports into the Design Quality Department, likely within a broader SQR (Supplier Quality & Regulatory) or Product Quality function, and collaborates closely with R&D, Manufacturing, and Regulatory Affairs.

Methodology:

• Emphasis on Quality by Design (QbD) principles to embed quality and safety from the earliest stages of product development.

• Application of lean process thinking and continuous improvement methodologies to optimize workflows and enhance efficiency.

• Data-driven decision-making, leveraging quality metrics and performance indicators to guide strategy and identify areas for enhancement.

Company Website: https://www.freseniusmedicalcare.com/

📝 Enhancement Note: Fresenius Medical Care's industry (healthcare, medical devices) dictates a culture heavily focused on quality, compliance, safety, and reliability. The global presence means a diverse workforce and potential for cross-cultural management. The "In Center" product portfolio suggests a focus on dialysis and related equipment.

📈 Career & Growth Analysis

Operations Career Level: This is a senior leadership role, Head of a global function. It represents a significant step up in responsibility, managing a distributed team and setting strategic direction for Design Quality Assurance across a major business unit. This level requires strategic thinking, strong leadership acumen, and deep domain expertise.

Reporting Structure: The Head of DQA will report to a Director or Vice President level within the Design Quality, Product Quality, or broader Quality & Regulatory Affairs organization. They will manage a team of DQA professionals, potentially including other team leads or managers in different regions.

Operations Impact: This role directly impacts the company's ability to bring safe and effective medical devices to market compliantly and efficiently. Successful DQA leadership ensures adherence to regulations, reduces risks associated with product development, supports faster regulatory submissions, and minimizes costly recalls or non-compliance issues, thereby safeguarding revenue and brand reputation.

Growth Opportunities:

• Executive Leadership: Potential to advance to Director or VP roles within Quality Assurance, Regulatory Affairs, or even broader operational leadership roles within Fresenius Medical Care.

• Functional Specialization: Opportunity to deepen expertise in specific areas of medical device quality, such as software quality assurance, cybersecurity in medical devices, or advanced risk management methodologies.

• Broader Operational Scope: Possibility to move into roles overseeing quality for multiple business units or expanding into related operational areas like manufacturing quality or supplier quality management.

📝 Enhancement Note: A "Head of" role in a large enterprise typically signifies a significant career milestone, offering opportunities for further executive advancement or deeper specialization within the quality and regulatory domain. The global scope and strategic impact on product development are key indicators of growth potential.

🌐 Work Environment

Office Type: The role is designated as "On-site" with primary locations in Bad Homburg and Schweinfurt, Germany. This suggests a traditional office-based work environment within Fresenius Medical Care's facilities.

Office Location(s): Bad Homburg vor der Höhe, Hesse, Germany; Schweinfurt, Bavaria, Germany. These locations offer access to well-established corporate infrastructure and professional networks.

Workspace Context:

• The workspace will likely be a dedicated office environment within the company's headquarters or a major site, providing access to necessary resources and collaborative spaces.

• Expect a professional, corporate setting with a strong emphasis on compliance and structured processes, typical of the medical device industry.

• Opportunities for direct interaction with cross-functional team members (R&D, Regulatory, Manufacturing) will be crucial for effective collaboration and problem-solving.

Work Schedule: A standard full-time schedule (approx. 40 hours/week) is expected, but as a leadership role with global responsibilities, flexibility will likely be required to manage time zone differences and critical project deadlines. This might involve early morning or late afternoon calls with international teams.

📝 Enhancement Note: The "On-site" designation and specific German locations indicate a traditional office-based setup. The nature of a global leadership role within a large medical device company suggests a structured, professional environment with a strong emphasis on collaboration and adherence to established protocols.

📄 Application & Portfolio Review Process

Interview Process:

• Initial Screening: A recruiter or HR representative will likely conduct an initial call to assess basic qualifications, experience, and cultural fit. Be prepared to articulate your relevant leadership experience and understanding of medical device quality.

• Hiring Manager Interview: A detailed discussion with the hiring manager (likely a Director or VP) focusing on your strategic approach to DQA, team leadership philosophy, and problem-solving capabilities. Expect questions about your experience managing global teams and driving process improvements.

• Panel Interview: This may involve interviews with key cross-functional stakeholders from R&D, Regulatory Affairs, and Manufacturing. The focus will be on your ability to collaborate, influence, and ensure alignment across departments. They will assess your understanding of design control and regulatory requirements from different perspectives.

• Case Study/Presentation: You may be asked to prepare and present a case study demonstrating your approach to a complex DQA challenge, a strategic initiative you led, or a significant process improvement you implemented. This is where your portfolio will be critical.

• Final Interview: Potentially with senior leadership to confirm strategic alignment and suitability for the role.

Portfolio Review Tips:

• Strategic Impact Focus: Highlight projects where your DQA leadership directly contributed to successful product launches, regulatory approvals, or significant improvements in product safety and compliance. Quantify impact where possible (e.g., reduced audit findings, faster time-to-market, improved process efficiency).

• Global Leadership Examples: Showcase experience managing distributed teams, harmonizing processes across different regions, and addressing cultural nuances in quality management.

• Process Innovation: Include examples of how you've developed, optimized, or implemented new design control processes, risk management frameworks, or quality management system enhancements.

• Regulatory Acumen: Clearly demonstrate your in-depth knowledge of key regulations (FDA, EU MDR, ISO 13485/14971) and how you've ensured compliance.

• Conciseness and Clarity: Organize your portfolio logically, using clear headings and concise descriptions. Be prepared to walk through specific examples and answer detailed questions.

Challenge Preparation:

• Anticipate questions about how you would approach harmonizing DQA across the global organization, developing a DQA strategy for new product types (e.g., digital health), or handling a significant regulatory non-compliance issue.

• Practice articulating your leadership style, decision-making process, and approach to conflict resolution within a cross-functional team.

• Be ready to discuss your vision for the future of Design Quality Assurance in the medical device industry.

📝 Enhancement Note: The interview process for a senior leadership role like this is multi-faceted, assessing strategic thinking, leadership capabilities, technical expertise, and cross-functional collaboration. A well-structured portfolio showcasing strategic impact and global leadership is crucial.

🛠 Tools & Technology Stack

Primary Tools:

• Quality Management System (QMS) Software: Experience with QMS platforms for document control, CAPA management, change control, and design history file (DHF) management (e.g., MasterControl, Veeva QMS, Sparta Systems TrackWise, or similar enterprise-level solutions).

• Product Lifecycle Management (PLM) Systems: Familiarity with PLM tools that integrate design, engineering, and quality data (e.g., Siemens Teamcenter, PTC Windchill, Dassault Systèmes ENOVIA).

• Collaboration & Project Management Tools: Proficiency in platforms like Microsoft Teams, Jira, Confluence, or Asana for global team communication, project tracking, and workflow management.

Analytics & Reporting:

• Business Intelligence (BI) Tools: Experience with BI platforms for data analysis and reporting on quality metrics, KPIs, and trends (e.g., Tableau, Power BI, QlikView).

• Spreadsheet Software: Advanced proficiency in Microsoft Excel for data analysis, modeling, and reporting.

CRM & Automation:

• While not a primary CRM role, understanding how R&D or manufacturing data might integrate with CRM systems for product feedback loops could be beneficial.

• Familiarity with workflow automation tools within QMS or PLM systems to streamline design control processes.

📝 Enhancement Note: For a Head of DQA role in medical devices, proficiency with enterprise-level QMS and PLM software is critical. These systems are the backbone of design control and regulatory compliance. Analytics tools are also important for performance monitoring and strategic decision-making.

👥 Team Culture & Values

Operations Values:

• Quality & Patient Safety: Paramount importance, driving every decision and process to ensure the highest standards for patient well-being.

• Compliance & Integrity: Upholding strict adherence to all applicable regulations and ethical standards without compromise.

• Innovation & Continuous Improvement: Fostering an environment that encourages new ideas, embraces data-driven enhancements, and proactively seeks to optimize processes and products.

• Collaboration & Accountability: Promoting strong teamwork across departments and functions, with clear ownership and accountability for delivering on objectives.

• Global Mindset & Diversity: Valuing diverse perspectives and experiences to drive better decision-making and create an inclusive work environment.

Collaboration Style:

• Cross-functional Partnership: A highly collaborative approach is essential, working closely with R&D, Regulatory Affairs, Manufacturing, and other quality functions to ensure seamless integration of design quality throughout the product lifecycle.

• Proactive Communication: Open, transparent, and frequent communication is key, especially with a globally distributed team, to align on strategies, resolve issues, and share best practices.

• Influential Leadership: The ability to influence stakeholders at various levels, build consensus, and drive adoption of quality standards and processes is vital.

📝 Enhancement Note: The culture at a company like Fresenius Medical Care in the medical device sector will heavily emphasize quality, safety, and compliance. The emphasis on global leadership and a diverse team points to a need for strong collaboration and cross-cultural understanding.

⚡ Challenges & Growth Opportunities

Challenges:

• Global Process Harmonization: Standardizing design quality assurance processes across diverse geographical regions, regulatory landscapes, and existing local practices can be complex and require significant change management.

• Integrating Digital & Traditional Products: Ensuring consistent quality and compliance for a portfolio that spans active, non-active, and digital medical devices, each with unique development and regulatory pathways.

• Talent Development & Retention: Attracting and retaining skilled DQA professionals in a competitive market, particularly for a globally distributed team, and ensuring continuous upskilling to meet evolving regulatory and technological demands.

• Balancing Innovation with Compliance: Enabling rapid innovation and product development timelines while maintaining rigorous adherence to stringent regulatory requirements and ensuring robust design controls.

Learning & Development Opportunities:

• Advanced Regulatory Training: Access to specialized training and conferences on emerging regulations (e.g., AI in medical devices, cybersecurity) to stay ahead of industry changes.

• Leadership Development Programs: Opportunities to hone strategic leadership, change management, and cross-cultural communication skills through internal programs or external executive coaching.

• Industry Best Practices: Engaging with professional organizations and industry forums to share knowledge, learn from peers, and contribute to the evolution of design quality assurance practices.

• Cross-functional Exposure: Potential to gain deeper insights into manufacturing, supply chain, or other operational areas through strategic collaborations and projects.

📝 Enhancement Note: The challenges outlined are typical for senior leadership roles in large, global, regulated industries, focusing on complexity, change management, and strategic alignment. The growth opportunities emphasize continuous learning and advancement within the quality and leadership domains.

💡 Interview Preparation

Strategy Questions:

• "Describe your approach to developing and implementing a global Design Quality Assurance strategy for a diverse product portfolio (active, non-active, digital)." - Preparation: Focus on your framework for assessment, stakeholder engagement, phased rollout, and metrics for success.

• "How would you foster a culture of continuous improvement and operational excellence within a globally distributed DQA team?" - Preparation: Discuss lean methodologies, empowerment, feedback mechanisms, and celebrating successes.

Company & Culture Questions:

• "What do you know about Fresenius Medical Care and its position in the medical device market?" - Preparation: Research the company's mission, product lines (especially In Center), recent news, and regulatory focus.

• "How do you envision the role of DQA evolving in the medical device industry, particularly with advancements in digital health and AI?" - Preparation: Be ready to discuss future trends, emerging risks, and proactive strategies.

Portfolio Presentation Strategy:

• Structure: Organize your presentation around key strategic initiatives, process improvements, or leadership achievements. Use a clear narrative for each example, outlining the challenge, your solution, the implementation, and the measurable results.

• Metrics: Quantify your impact wherever possible. For example, "Reduced design review cycle time by 15%," "Achieved 100% compliance in the last FDA audit for DHF documentation," or "Successfully onboarded and trained 20 new DQA engineers across three continents."

• Visuals: Use clear, professional slides with minimal text. Incorporate diagrams for processes or charts for data visualization.

• Storytelling: Frame your experiences as compelling stories that demonstrate your leadership, problem-solving abilities, and strategic thinking in a DQA context.

📝 Enhancement Note: The interview preparation focuses on strategic thinking, leadership, and practical application of DQA principles within the medical device context, emphasizing the need to connect past experiences to future contributions at Fresenius Medical Care.

📌 Application Steps

To apply for this Head of Design Quality Assurance position:

• Submit your application through the Fresenius Medical Care careers portal via the provided URL.

• Tailor Your Resume: Ensure your resume highlights leadership experience, global team management, expertise in medical device regulations (FDA, EU MDR, ISO 13485, ISO 14971), and process improvement initiatives. Use keywords from the job description to improve ATS compatibility.

• Prepare Your Portfolio: Compile a concise portfolio showcasing 2-3 key projects or initiatives that demonstrate your strategic leadership, global DQA management, and process optimization successes. Focus on quantifiable results and regulatory compliance.

• Practice Your Narrative: Be ready to articulate your leadership philosophy, strategic vision for DQA, and how you would approach the challenges specific to Fresenius Medical Care's product portfolio and global operations. Practice presenting your portfolio highlights effectively.

• Research Fresenius Medical Care: Understand the company's mission, values, and its specific role in the healthcare industry. Be prepared to discuss how your leadership style and DQA approach align with their culture and objectives.

⚠️ Important Notice: This enhanced job description includes AI-generated insights and operations industry-standard assumptions. All details should be verified directly with the hiring organization before making application decisions.