Are you looking for more than just a job, for something truly meaningful and rewarding? Then Sysmex Europe SE is the place for you. As the regional headquarters for the EMEA (Europe, Middle East and Africa) region, our company is dedicated to providing essential products that help people worldwide on their healthcare journey.

If this opportunity appeals to you, come and join us in the position of

Team Lead (f/m/x) Software Quality Assurance

What if you could take ownership of software quality for medical solutions that directly impact patient safety worldwide? As Team Lead (f/m/x) Software Quality Assurance, you lead and shape our QA organization within a regulated MedTech environment. You combine strategic responsibility with hands-on leadership, drive modern automation and validation approaches, and act as a key authority for quality and compliance across the organization. Your key responsibilities include:

Leadership & Accountability

• Providing clear direction, operational leadership, and continuous improvement for a QA team of 10–15 professionals
• Defining and driving QA strategies, test plans, and test processes aligned with regulatory requirements, product development goals, and emerging technologies from early prototyping to product market release
• Acting as the primary QA representative during internal and external audits
• Serving as a thought leader for quality assurance, fostering a culture of quality, innovation, and continuous improvement across the organization

Automation & Test Infrastructure

• Leading the design, implementation, and continuous evolution of scalable test automation frameworks integrated into CI/CD pipelines
• Overseeing the creation, operation, and maintenance of real-world test environments and clinical-grade validation labs
• Adapting and optimizing QA processes to address complex challenges such as cybersecurity requirements for on-premise software and cloud-based services
• Ensuring verification and validation activities are tailored to the respective deployment contexts, including simulated, real-world, and production-like environments
• Introducing modern tools, methodologies, and best practices to accelerate testing and validation cycles

Regulatory Compliance & Governance

• Ensuring full compliance with ISO 14971, ISO 13485, IEC 62304, and other applicable regulatory standards
• Maintaining audit-ready documentation, traceability, and evidence for all verification and validation activities
• Collaborating closely with Regulatory Affairs to ensure timely, accurate compliance reporting
• Acting as the QA compliance authority for audits, governance topics, and external validation programs

Team Development & Collaboration

• Building, mentoring, and empowering an agile, high-performing QA team with expertise in automation, compliance, and performance testing
• Fostering strong collaboration with Software Engineering, Product Management, and regional and global QA stakeholders
• Communicating quality metrics, risks, and improvement initiatives clearly and transparently to senior management and key stakeholders

You will thrive in this role if you combine strong leadership capabilities with deep expertise in software quality assurance within regulated environments and a passion for building modern, future-ready QA organizations. Ideally, you bring the following qualifications and strengths:

• A degree in Computer Science, Engineering, or a related technical field
• 5+ years of professional experience in software quality assurance, including at least 3 years in a leadership role within a regulated industry (MedTech preferred)
• Proven expertise in test automation frameworks, CI/CD integration, and the execution of compliance and regulatory audits
• Strong knowledge of ISO and IEC standards applicable to medical software development
• Experience working with both on-premise and cloud-based software solutions
• Solid understanding of agile as well as traditional software development methodologies
• A confident leadership style combined with excellent communication and stakeholder management skills
• Fluency in English; German language skills are a plus
• Experience with AI/ML technologies and data-driven healthcare applications is an advantage

We are an aspiring corporate group where respect and trust form the basis for cooperation and communication within Sysmex.

• Culture & cooperation
  An appreciative work environment, open corporate culture, flat hierarchies and an inclusive and caring atmosphere. Working in an innovative and international environmentwith a broad learning and development landscape in our EMEA Campus, after-work events for internal networking
• Work-life balance
  Flexible working through flextime and a hybrid working model (60% mobile working, 40% on-site), 30 days annual leave
• Additional benefits
  Attractive compensation package including Christmas and vacation pay, childcare allowance, capital-forming benefits, subsidy for company pension scheme, corporate benefits, relocation assistance, subsidised lunch in our canteen
• Health & wellbeing
  In-house gym, various sports courses, massages, company medical and psychological care, workplace glasses, general health management
• Mobility
  Subsidy for the public transport “Deutschlandticket”, free parking, bike leasing via JobRad
• Social Responsibility
  Various opportunities to get involved in different sustainability and charity initiatives, climate friendly and respectful use of resources