10-10-2025 | reference no 010921 Quality-Management-System Manager (f/m/x) Place of Work Hambur[...]

### Your responsibilitiesAs **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### Your profileIdeally, 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### Our benefitsWe 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 resourcesWorking Experience2 to 5 years
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