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; Palazzo Pignano, Italy; Schweinfurt, Germany

Job Type: FULL_TIME

Category: Quality Assurance / Operations Management

Date Posted: 2026-05-21

Experience Level: 5-10 Years

Remote Status: Hybrid

🚀 Role Summary

• Lead the global Design Quality Assurance (DQA) team, encompassing active, non-active, and digital medical devices, to ensure consistent and compliant design control processes.

• Define and execute a global DQA strategy and operating model, fostering operational excellence and continuous improvement across diverse product categories and regions.

• Drive team development through strategic resource planning, capability building, and competency mapping for a globally distributed team (US, Mexico, Europe, China).

• Act as a key liaison between Development, Regulatory Affairs, Manufacturing, and Quality functions to ensure robust product safety and quality by design.

📝 Enhancement Note: This role is positioned as a senior leadership position within Quality Assurance, with a strong emphasis on global operations management, process harmonization, and strategic implementation of design control frameworks. The "f/m/d" (female/male/diverse) designation indicates an inclusive hiring practice common in German job postings. The hybrid work arrangement suggests a need for on-site presence for team leadership and critical meetings, while allowing for remote flexibility.

📈 Primary Responsibilities

• Provide global disciplinary and functional leadership for the Design Quality Assurance (DQA) group, overseeing all product types and geographical regions.

• Develop and implement the global DQA strategy and operating model, ensuring consistent application of design control principles across the organization.

• Drive team development initiatives, including resource allocation, talent development, competency assessment, and succession planning for the DQA team.

• Ensure efficient task management, optimal resource utilization, and high-performance delivery from the global DQA workforce.

• Cultivate a culture of continuous improvement, lean process methodologies, and operational excellence within the DQA function.

• Represent the DQA function in global and local leadership forums, quality committees, and cross-functional governance bodies.

• Contribute strategically to the Design Quality leadership team, collaborating on global initiatives, process enhancements, and functional alignment.

• Establish and maintain a global framework for compliant and efficient design control across product lines, technologies, and regions.

• Serve as a vital contributor to regulatory readiness, innovation enablement, and enhancing the overall design quality maturity of the Business Unit.

• Coordinate and oversee the execution of design control activities for all product development and design change projects.

• Ensure adherence to critical 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).

• Establish and manage robust design quality processes and supporting documentation systems, including design reviews, phase gates, and comprehensive documentation management.

• Monitor and ensure global consistency and high performance in design assurance execution, with clear accountability for deliverables concerning quality, timeliness, and cost-effectiveness.

• Collaborate closely with manufacturing and supplier quality teams to facilitate seamless design transfer and effective product realization processes.

📝 Enhancement Note: The responsibilities highlight a dual focus on strategic leadership (defining strategy, operating models, representing the function) and operational execution (coordinating activities, ensuring compliance, managing deliverables). The emphasis on global leadership and cross-functional collaboration is a key differentiator for this role.

🎓 Skills & Qualifications

Education:

Experience:

Required Skills:

• Advanced knowledge of global medical device regulations, including but not limited to FDA 21 CFR 820, EU Medical Device Regulation (MDR 745/2017), NMPA regulations, and MDSAP.

• Advanced understanding of applicable quality management standards (e.g., ISO 13485) and risk management standards (e.g., ISO 14971).

• Solid knowledge of Corrective and Preventive Action (CAPA) methodology and its application in quality systems.

• Familiarity with internal and external processes, organizational structures, and corporate quality management requirements.

• Profound knowledge of the Medical Device field and its practical applications.

• High engagement and commitment to achieving targets and position objectives, with a proactive and solution-oriented approach to problem-solving.

• Ability to work effectively cross-functionally with employees at all levels of the organization.

• Strong professional relationships and effective communication skills with international colleagues and superiors.

Preferred Skills:

• Experience with IEC 62304 for software lifecycle processes.

• Familiarity with ICH Q10, EU GMP, and other relevant pharmaceutical quality guidelines if applicable to certain product lines.

• Experience in leading or managing globally distributed teams.

• Demonstrated ability in strategic planning and implementation of quality assurance frameworks.

• Experience with digital health products or software as a medical device (SaMD).

📝 Enhancement Note: The requirements emphasize deep regulatory and quality system knowledge specific to medical devices, combined with strong leadership and cross-functional communication skills. The bilingual requirement (English/German) is critical for operating within Fresenius Medical Care's global structure, particularly with European operations.

📊 Process & Systems Portfolio Requirements

Portfolio Essentials:

• Demonstrate a proven track record of successfully implementing and optimizing design control processes within a regulated environment, ideally medical devices.

• Showcase examples of how you have driven regulatory compliance and product safety improvements through effective design quality assurance strategies.

• Provide evidence of experience in harmonizing processes across different regions or business units, highlighting successful integration of quality frameworks.

Process Documentation:

• Examples of robust design control documentation, including design history files (DHFs), design review minutes, and risk management files.

• Documentation showcasing the implementation of phase-gate reviews and their effectiveness in project progression.

• Evidence of process improvement initiatives within design quality assurance, including metrics for efficiency and compliance enhancements.

• Samples of standard operating procedures (SOPs) or work instructions related to design control, risk management, or CAPA processes.

📝 Enhancement Note: For a Head of Design QA role, the portfolio should go beyond individual contributions to demonstrate strategic thinking, process design, and team leadership. The focus should be on systemic improvements and demonstrable impact on compliance and product quality at a global scale.

💵 Compensation & Benefits

Salary Range:

Benefits:

• Comprehensive health insurance coverage, aligned with German statutory requirements and potentially enhanced company-specific plans.

• Pension scheme contributions and retirement planning support.

• Generous paid time off, including vacation days and public holidays, in line with German labor laws.

• Opportunities for professional development, including advanced training, certifications, and conference attendance.

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

• Support for hybrid work arrangements, including potential for home office stipends or equipment.

• Employee assistance programs offering confidential support for personal and professional challenges.

Working Hours:

• Standard full-time employment is typically 40 hours per week. The role may offer flexibility in terms of daily start and end times, aligning with the hybrid work model and the need for global team coordination across different time zones.

📝 Enhancement Note: Salary estimates are based on regional market data for senior Quality Assurance roles in Germany, factoring in the specific industry (medical devices) and the leadership scope. Benefits are typical for large, multinational corporations in Germany.

🎯 Team & Company Context

🏢 Company Culture

Industry: Healthcare / Medical Devices. Fresenius Medical Care is a global leader in products and services for individuals undergoing dialysis. The company's mission is to improve the lives of patients with kidney disease through innovative products and services, focusing on quality, safety, and patient outcomes. This industry context demands rigorous adherence to quality standards and regulatory compliance.

Company Size: Fresenius Medical Care is a large, publicly traded company with tens of thousands of employees globally. This scale implies established processes, a structured organizational hierarchy, and significant resources for R&D, quality, and manufacturing.

Founded: Fresenius Medical Care was founded in 1996 as a merger of Fresenius AG's dialysis business and National Medical Care. This history suggests a company with deep roots in healthcare innovation and a long-standing commitment to patient care.

Team Structure:

• The DQA team is part of the broader SQR – In Center Product Quality & CE Supplier Quality – Design Quality Department. This structure indicates a centralized quality function with specialized groups for different aspects of product quality and supplier oversight.

• The Head of DQA will have disciplinary leadership over a globally distributed team across the US, Mexico, Europe, and China, implying a matrixed reporting structure where functional leadership is key.

Methodology:

• A strong emphasis on data-driven decision-making, evidenced by the need for performance monitoring and metrics.

• A commitment to continuous improvement and lean principles, as stated in the responsibilities.

• A focus on robust process design and implementation, crucial for meeting stringent medical device regulations.

• A culture that values quality by design, integrating quality considerations from the earliest stages of product development.

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

📝 Enhancement Note: The company's focus on healthcare and patient well-being underscores the critical importance of quality and regulatory compliance. The global nature of operations necessitates strong cross-cultural communication and process harmonization skills.

📈 Career & Growth Analysis

Operations Career Level: This role represents a senior leadership position within the operations and quality assurance domain. It is a strategic role responsible for defining and executing a global function, managing a distributed team, and influencing company-wide quality policies. This level typically requires extensive experience and a proven track record in quality management and regulatory affairs within highly regulated industries.

Reporting Structure: The Head of DQA will likely report to a senior executive within the Quality or R&D organization, such as a Vice President of Quality, Chief Quality Officer, or Head of R&D. They will have direct reports managing DQA activities across different regions.

Operations Impact: The Head of DQA has a profound impact on the company's ability to bring safe and effective medical devices to market. Their oversight ensures compliance with global regulations, mitigates risks associated with product development, and directly influences product launch timelines and market access. Effective design quality assurance is foundational to patient safety and the company's reputation and financial success.

Growth Opportunities:

• Leadership Expansion: Potential to move into broader quality leadership roles, such as VP of Quality, Chief Quality Officer, or Head of Global Quality Operations.

• Strategic Development: Opportunity to shape the future of design quality assurance at Fresenius Medical Care, influencing global strategy and implementing cutting-edge quality methodologies.

• Cross-Functional Leadership: Possibility to transition into related leadership roles in Regulatory Affairs, R&D, or Operations Management, leveraging a deep understanding of the product lifecycle.

• Industry Influence: Engagement in industry forums, standards committees, or professional organizations related to medical device quality and regulatory affairs.

📝 Enhancement Note: This role offers significant career progression opportunities within a large, stable healthcare company. The global scope and strategic importance of the position provide a strong foundation for advancement into executive leadership roles.

🌐 Work Environment

Office Type: The role is designated as Hybrid, indicating a blend of on-site work at one of the specified office locations (Bad Homburg, Germany; Palazzo Pignano, Italy; or Schweinfurt, Germany) and remote work. This setup is common for leadership roles that require both team interaction and flexibility.

Office Location(s):

• Bad Homburg, Germany: A significant corporate hub, likely offering comprehensive facilities and a strong professional network.

• Palazzo Pignano, Italy: May represent a specific R&D or manufacturing site, potentially offering a different operational focus.

• Schweinfurt, Germany: Another German location, possibly related to specific product lines or manufacturing operations.

Workspace Context:

• The hybrid model supports a flexible work schedule, allowing for focused individual work at home and collaborative sessions, team meetings, and strategic discussions in the office.

• Access to relevant quality management systems, documentation platforms, and communication tools will be essential.

Work Schedule:

• A standard 40-hour work week is expected, with flexibility in daily scheduling to accommodate global team interactions across different time zones. This may involve occasional early morning or late afternoon calls.

📝 Enhancement Note: The hybrid work arrangement necessitates strong self-management and communication skills. The choice of office location might depend on team distribution and strategic alignment with specific business units or R&D centers.

📄 Application & Portfolio Review Process

Interview Process:

• Initial Screening: A review of your application, resume, and potentially a cover letter to assess alignment with the core requirements and experience.

• Hiring Manager Interview: A discussion with the direct hiring manager to delve into your experience, leadership style, and strategic approach to design quality assurance. Be prepared to discuss your DQA strategy and team management philosophy.

• Team/Stakeholder Interviews: Interviews with key team members (e.g., DQA leads in different regions) and cross-functional stakeholders (e.g., R&D managers, regulatory affairs leads, manufacturing leads). This assesses your collaboration style, technical expertise, and ability to influence.

• Case Study/Presentation: A potential requirement to present a case study on a significant design quality assurance challenge you've managed, a process improvement initiative, or a strategic plan. Focus on demonstrating your problem-solving, strategic thinking, and communication skills.

• Final Interview: Typically with a senior executive (e.g., VP of Quality) to assess overall fit, leadership potential, and strategic vision for the DQA function.

Portfolio Review Tips:

• Global Strategy Focus: Highlight examples where you developed or implemented global quality strategies, harmonized processes, or managed distributed teams.

• Process Improvement Case Studies: Select 1-2 strong examples of how you improved design control processes, enhanced regulatory compliance, or reduced product development risks, quantifying the impact (e.g., reduced audit findings, faster design transfer, improved product quality metrics).

• Regulatory Expertise: Be ready to discuss your experience with specific regulations (FDA 21 CFR 820, EU MDR, ISO 13485, ISO 14971) and how you ensure compliance.

• Leadership & Team Management: Showcase your approach to team development, resource planning, and fostering a culture of quality and continuous improvement.

• Conciseness and Clarity: Present information clearly and concisely, focusing on your role, actions, and the measurable results achieved.

Challenge Preparation:

• Strategic Vision: Be prepared to articulate your vision for Design Quality Assurance at Fresenius Medical Care, considering the company's global footprint and product portfolio.

• Problem-Solving Scenarios: Anticipate questions about how you would handle common challenges, such as regulatory non-compliance, delayed design reviews, or cross-functional conflicts.

• Change Management: Consider how you would lead change initiatives to implement new processes or technologies within the DQA function across different regions.

📝 Enhancement Note: The interview process for a leadership role of this caliber will be rigorous, focusing heavily on strategic thinking, global leadership capabilities, and demonstrable impact. A well-curated portfolio showcasing strategic initiatives and measurable results is crucial.

🛠 Tools & Technology Stack

Primary Tools:

• Quality Management System (QMS) Software: Experience with QMS platforms (e.g., Veeva QMS, MasterControl, Sparta Systems TrackWise) for managing documentation, CAPA, change control, and design history files.

• Document Management Systems (DMS): Proficiency in systems for controlling and archiving design documents, SOPs, and records.

• Project Management Tools: Familiarity with tools like Jira, Asana, or Microsoft Project for tracking development projects and design phase gates.

• Collaboration Platforms: Experience with Microsoft Teams, Slack, or similar for global team communication and collaboration.

Analytics & Reporting:

• Data Analysis Tools: Ability to analyze quality data, identify trends, and generate reports using tools like Excel, Tableau, Power BI, or specialized statistical software.

• QMS Reporting Modules: Expertise in leveraging reporting functionalities within QMS software to track key quality indicators (KQIs) and performance metrics.

CRM & Automation:

• While not a direct CRM role, understanding how CRM data might interface with product feedback or customer complaint systems (which can feed into design improvements) is beneficial.

• Experience with workflow automation within QMS or project management tools to streamline design control processes.

• Integration Tools: Understanding of how different systems (e.g., PLM, ERP, QMS) might integrate to provide a holistic view of product development and quality.

📝 Enhancement Note: While specific software isn't listed, a strong foundation in QMS, document control, and project management tools is essential. The ability to leverage data analytics for quality improvement and reporting is also key for this leadership role.

👥 Team Culture & Values

Operations Values:

• Patient Centricity: A core value in healthcare, ensuring all quality efforts ultimately contribute to patient safety and well-being.

• Integrity & Compliance: Upholding the highest ethical standards and ensuring strict adherence to all applicable regulations and internal policies.

• Excellence & Continuous Improvement: A commitment to delivering high-quality work and constantly seeking ways to enhance processes, efficiency, and effectiveness.

• Collaboration & Teamwork: Fostering an environment where diverse teams work together effectively across geographical boundaries to achieve common goals.

• Innovation: Encouraging creative solutions and forward-thinking approaches to quality assurance and product development.

Collaboration Style:

• Global & Cross-Functional: The role demands a highly collaborative style, working seamlessly with R&D, Regulatory Affairs, Manufacturing, Supplier Quality, and other global quality teams.

• Data-Driven & Objective: Decisions and discussions should be based on data and objective evidence, fostering a culture of trust and accountability.

• Proactive & Solution-Oriented: A proactive approach to identifying potential issues and collaboratively developing effective solutions.

• Open Communication: Encouraging transparent and open communication channels to ensure alignment and address challenges effectively.

📝 Enhancement Note: The company culture at Fresenius Medical Care, typical of large healthcare organizations, will likely emphasize patient well-being, regulatory adherence, and a commitment to quality. The Head of DQA must embody these values and foster them within their team and through their cross-functional interactions.

⚡ Challenges & Growth Opportunities

Challenges:

• Global Harmonization: Ensuring consistent application of design control processes and quality standards across diverse regions with varying regulatory landscapes and cultural nuances.

• Team Management: Leading and developing a globally distributed team, managing performance, and fostering a cohesive team culture across different time zones and work environments.

• Regulatory Evolution: Keeping pace with evolving global medical device regulations (e.g., EU MDR, FDA updates) and ensuring the organization's design control processes remain compliant.

• Balancing Innovation and Compliance: Supporting product innovation and speed-to-market while rigorously maintaining design control and regulatory compliance.

• Cross-Functional Alignment: Effectively influencing and collaborating with R&D, manufacturing, and regulatory affairs to ensure seamless integration of quality into the product lifecycle.

Learning & Development Opportunities:

• Advanced Regulatory Training: Deepening expertise in emerging regulatory requirements and global compliance strategies for medical devices.

• Leadership Development Programs: Participating in executive leadership training to enhance strategic decision-making, change management, and global team leadership skills.

• Industry Conferences & Seminars: Attending leading industry events to stay abreast of best practices, emerging trends, and network with peers.

• Mentorship: Access to senior leaders within Fresenius Medical Care for guidance and career development.

• Process Optimization Certifications: Pursuing certifications in Lean, Six Sigma, or other process improvement methodologies to further enhance operational efficiency.

📝 Enhancement Note: The challenges presented are inherent to a senior leadership role in a global, highly regulated industry. The growth opportunities are tailored to enhance leadership capabilities, regulatory expertise, and strategic influence within the organization.

💡 Interview Preparation

Strategy Questions:

• "Describe your vision for a world-class global Design Quality Assurance function within the medical device industry. What are the key pillars of this vision?"

• "How would you approach harmonizing design control processes across different geographical regions, considering varying regulatory requirements and local operational practices?"

Company & Culture Questions:

• "Based on your understanding of Fresenius Medical Care, how would you ensure the DQA function aligns with the company's mission to improve patient lives?"

• "How do you foster a culture of quality and continuous improvement within your team and across cross-functional departments?"

Portfolio Presentation Strategy:

• Structure: Organize your presentation around 2-3 key projects or initiatives that demonstrate your strategic impact, leadership, and results. Use the STAR method (Situation, Task, Action, Result) for each.

• Metrics are Key: Quantify your achievements. Instead of saying "improved compliance," say "reduced non-conformances by 20% by implementing a new design review checklist."

• Global Impact: Emphasize any experience with global teams, international regulations, or process harmonization efforts.

• Problem-Solving Narrative: Clearly articulate the challenge, your thought process, the actions taken by you and your team, and the measurable benefits achieved.

• Visual Aids: Use clear, concise slides with minimal text. Focus on visuals like process flow diagrams, charts, and graphs to illustrate your points.

📝 Enhancement Note: Interview preparation should focus on demonstrating strategic thinking, global leadership capabilities, deep regulatory knowledge, and a results-oriented approach. Be prepared to discuss specific examples from your experience that align with the responsibilities and requirements of the role.

📌 Application Steps

To apply for this operations position:

• Submit your application through the provided application link on the Fresenius Medical Care careers portal.

• Tailor Your Resume: Ensure your resume clearly highlights your experience in medical device quality assurance, design control, regulatory compliance (mentioning specific regulations like FDA 21 CFR 820, EU MDR, ISO 13485), and global team leadership. Quantify your achievements with metrics wherever possible.

• Prepare Your Portfolio: Curate 2-3 key projects or initiatives that showcase your strategic approach to design quality assurance, process improvement, and team management. Be ready to present these in detail, focusing on your role, actions, and measurable outcomes.

• Research Fresenius Medical Care: Understand their product lines, mission, and recent developments. Familiarize yourself with their commitment to quality and patient care.

• Practice Interview Responses: Prepare answers to common leadership and quality assurance interview questions, and rehearse your portfolio presentation to ensure clarity, conciseness, and impact.

⚠️ 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.