Quality-Management-System Manager

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

Sysmex provides global healthcare support with diverse medical diagnostics products and solutions. With more than 50 years' experience in in-vitro diagnostics, we improve the patients' healthcare journey.

Sysmex Europe SE, in Hamburg, Germany, is a regional headquarter for Europe, Africa and the Middle East and serves affiliates, distributors, and customers with over 2,500 employees in the EMEA region, living our mission "Together for a better healthcare journey " every day.

Hamburg Hamburg

As QMS Manager (f/m/x), you will play a pivotal role in ensuring the continuity and advancement of our ISO 13485-certified Quality Management System. You'll be the driving force behind quality helping us maintain compliance, improve processes, and foster a culture of excellence.

Your key responsibilities include:

• Maintain and enhance our ISO 13485-certified QMS, ensuring ongoing compliance and readiness for audits
• Contribute to the management of the designated QMS processes including but not limited to change control management, CAPA and internal audit management
• Deliver targeted trainings on quality management topics to foster awareness and competence
• Review and approve QMS documentation in our Document Management System (DMS) as the final quality approver
• Support cross-functional initiatives aligned with regulatory requirements and continuous improvement goals
• Conduct internal audits to assess compliance and identify opportunities for improvement
• Assist in external audits and inspections
• Act as ambassador of quality and support stakeholders across organization

Leonie Nolte

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Reference No.: 10921

Sysmex Europe SE, Deelböge 19D, 22297 Hamburg

Ideally, you bring the following qualifications and strengths:

• Degree in medical technology, biotechnology, or a related field; alternatively, equivalent professional experience
• In-depth knowledge of ISO 13485 and IVDR regulations
• Proven track record in implementing and maintaining ISO 13485 or similar quality standards
• Strong communication and decision-making skills, with a proactive and hands-on approach
• Fluent in German and English, both written and spoken

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
  
  Christmas and holiday bonuses, 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.