Quality Manager (f / m / x)

Sysmex; Hamburg; Hybrid; EUR 60.000 - 80.000; Vollzeit

Zusammenfassung

A leading healthcare technology company in Hamburg seeks a Quality Manager to ensure compliance with rigorous quality standards in diagnostic solutions. Key responsibilities include maintaining the ISO 13485 Quality Management System, conducting internal audits, and supporting product development teams. The ideal candidate has a degree in medical technology or a related field, a minimum of 3 years of experience in the relevant industry, and is fluent in German and English.

Leistungen

Flexible working model

30 days annual leave

Attractive compensation package

In-house gym and health programs

Subsidy for public transport

Opportunities for social responsibility

Qualifikationen

• Minimum 3 years of experience in Quality within medical device or IVD industry.
• Demonstrated experience managing design controls, including verification.
• Proven experience working with R&D teams in product development environment.

Aufgaben

• Maintain and improve ISO 13485 compliant Quality Management System.
• Ensure QMS supports R&D activities and design controls.
• Conduct internal audits to assess compliance and identify improvements.

Kenntnisse

ISO 13485 knowledge

Communication skills

Decision-making skills

Proactive approach

Fluent in German

Fluent in English

Ausbildung

Degree in medical technology or related field

Equivalent professional experience

Jobbeschreibung

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

Quality Manager (f / m / x)

As Quality Manager for in-vitro and molecular diagnostic research and development, you will ensure that all design processes and final products meet rigorous quality and regulatory standards to guarantee the safety, reliability, and compliance of Sysmex´s Diagnostic Solutions.

Your responsibilities

• Maintain, develop and continuously improve the company’s ISO 13485 compliant Quality Management System
• Ensure the QMS fully supports R&D activities, design controls, and technology transfer to manufacturing
• Oversee document control, training, internal audits, CAPA, nonconformities, change control processes
• Deliver targeted trainings on quality management topics to foster awareness and competence.
• Support the review and approval of the design documentation
• Support cross-functional development teams to ensure quality and regulatory requirements are built into product design from concept to launch
• 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 profile

• Degree in medical technology, biotechnology, or a related field; alternatively, equivalent professional experience.
• Minimum 3 years of experience in Quality within the medical device or IVD industry
• Demonstrated experience managing design controls, including verification, validation and design transfer processes
• Proven experience working with R&D teams in product development environment
• Strong knowledge of ISO 13485 and EU IVDR
• 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 benefits

• Culture & cooperation

  We are an aspiring corporate group where respect and trust form the basis for cooperation and communication within Sysmex, an appreciative work environment, open corporate culture, flat hierarchies and an inclusive and caring atmosphere. Working in an innovative and international environment with 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.

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