Your responsibilities

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

Your profile

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

Our benefits

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

Did we spark your interest? Then we look forward to receiving your application with salary requirements and the earliest possible starting date.