Quality Manager (f/m/x)

Quality Manager (f/m/x)

Your responsibilities

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. You will:

• 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
• Mandatory experience working with R&D and Product Management teams in regulated product development environments
• 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

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

Subsidized EGYM Wellpass with access to 13,500 studios, plus in-house gym, various sports courses, massages, company medical and psychological care, workplace glasses, and 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 the earliest possible starting date.

Do you have questions?

Reference No.: 11090