Production Quality Assurance Manager (f/m/x)

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

Our Company

Sysmex is shaping the future of healthcare diagnostics with innovation and passion. In our new, modern headquarters in Hamburg, we offer a collaborative and inspiring work environment designed for creativity and growth. As part of a global team, you will contribute to improving patients' healthcare journeys every day. Join us and experience a workplace that combines cutting-edge technology with a culture of openness and development and live our mission every day: "Together for a better healthcare journey."

Production Quality Assurance Manager (f/m/x)

Location

Hamburg Hamburg

Your responsibilities

What if you could be the one ensuring that every diagnostic product leaving our facilities is safe, reliable, and fully compliant with the highest quality standards?
As a Production Quality Assurance Manager (f/m/x) for in-vitro and molecular diagnostic production, you play a key role in safeguarding the integrity of Sysmex's Life Science diagnostic solutions. You ensure that production processes run in line with rigorous quality and regulatory requirements, working closely with our production teams in Hamburg and Neumünster. Your key responsibilities include:

• Following up on production-related nonconformities, supporting root cause analyses, defining and monitoring corrective actions, and preparing evaluations and statistics of nonconformities
• Managing production-related change control, including moderating the change board and coordinating all related actions
• Conducting and managing quality-management-related trainings and providing general QA support to production departments
• Reviewing and approving QMS documentation in the Document Management System (DMS) as the final quality approver
• Performing incoming inspections (IQC), reviewing manufacturing documentation for IVD kits, labeling, and Instructions for Use (IFU), and verifying QC test data for individual components and master lot releases
• Managing and approving QA release activities, including preparation of the Device History Record (DHR), batch tree review, physical inspections of packed kits, and creation of Certificates of Analysis (CoA)
• Reviewing and approving validation and verification plans, protocols, and reports for cleaning, production, and testing processes
• Supporting cross-functional initiatives aligned with quality requirements and continuous improvement goals
• Acting as a quality ambassador and providing guidance to stakeholders across production areas
• Supporting production teams during external audits, inspections, and third-party assessments

Do you have questions?

Léa Sanft
[email protected]
Reference No.: 10988

Sysmex Europe SE, Deelböge 19D, 22297 Hamburg

Your profile

You are a strong match for this role if you bring solid expertise in quality management within a regulated Life Science or diagnostic production environment and a deep commitment to ensuring product safety and compliance. Ideally, you bring the following qualifications and strengths:

• A completed education or degree in molecular biology, biotechnology, medical technology, or equivalent professional experience
• Profound knowledge of ISO 13485 and IVDR
• Proven experience in implementing ISO 13485 or other relevant standards
• Experience in production-related topics such as hygiene management, process validation, or batch record review
• Dedication and diligence in Quality Management and Quality Assurance topics
• Strong communication skills and the ability to make consistent, professional decisions with a hands-on mentality
• Excellent command of written and spoken German and English
• Availability to work on-site with the production teams in Hamburg and Neumünster

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.