Your Role

As Product Manager (f/m/x) Quality Control, you are responsible for managing quality control products used to monitor and ensure the performance of haematology analysers throughout their lifecycle, ensuring product performance, technical reliability and effective stakeholder support in an international IVD environment. By combining scientific expertise, analytical thinking and cross-functional collaboration, you contribute to delivering high-quality products and services across the EMEA region.

This is a fixed-term position with a duration of 18 months.

Your key responsibilities include:

• Managing quality control products throughout the entire product lifecycle, from introduction to phase-out
• Conducting assay assignment, statistical evaluation and performance monitoring to ensure product quality and reliability
• Providing and coordinating 2nd level support for Sysmex affiliates and distributors across the EMEA region
• Creating and maintaining product-related documentation for internal and external stakeholders
• Handling product complaints and driving the implementation of related processes, updates and corrective actions
• Maintaining and updating quality management documentation in alignment with ISO 13485 requirements
• Collaborating closely with internal stakeholders, including Technical Services, Supply Chain Management and Regulatory Affairs, to ensure effective product support and lifecycle management
• Supporting projects and continuous improvement initiatives related to product performance, quality processes and operational excellence

Your Profile

You are a strong match if you combine scientific expertise with a passion for quality, laboratory work and statistical evaluation. With your analytical mindset and structured approach, you contribute effectively to product excellence and cross-functional collaboration in a regulated international environment. Ideally, you bring the following qualifications and strengths:

• Degree in Biomedical Sciences, Life Sciences or a comparable scientific field
• Professional experience in a medical laboratory, the IVD industry or a comparable laboratory environment
• Understanding of laboratory workflows, quality control processes and diagnostic testing environments
• Knowledge of quality management systems and regulatory requirements, ideally including ISO 13485
• Experience in working effectively across functions and stakeholders
• Strong analytical and problem-solving skills with a particular passion for statistical evaluation, monitoring and data interpretation
• Accurate, independent and well-organized working style combined with strong communication and teamwork skills
• Fluent English language skills; German language skills are a plus
• Willingness to maintain regular on-site presence at our Hamburg laboratory, as required by laboratory activities and operational needs. Please note that the first three months of employment are fully on-site to ensure comprehensive onboarding and hands-on laboratory training. Long-term, the balance between on-site and remote work will depend on laboratory responsibilities and business requirements