A well-established European manufacturer of advanced systems for emergency and critical care is expanding its quality organization. With decades of experience and a strong international presence, the company develops and produces high-end medical technology used globally in demanding, safety-critical environments.

At the company’s main production and development site in Southern Germany, several hundred employees work together to deliver products that meet the highest regulatory and performance standards. Alongside innovation, the organization places strong emphasis on sustainable growth, modern working conditions, and long-term career development.

Your Role

As a Quality Manager (m/f/d), you play a key role in maintaining and advancing the company’s quality and compliance landscape. You ensure that quality management systems are not only compliant with applicable standards, but also continuously improved and aligned with future requirements.

Your responsibilities include:

• Planning, conducting, and following up on internal and external audits as well as management reviews
• Monitoring quality-related KPIs, analyzing trends, and deriving targeted improvement measures
• Coordinating CAPAs and handling non-conformities, including root cause analysis and effectiveness checks
• Collaborating with process owners to further develop quality-relevant processes and documentation
• Supporting and advancing the information security management system in line with ISO/IEC 27001
• Acting as a point of contact for regulatory inspections and authority inquiries (e.g. FDA)
• Delivering internal training and providing guidance to teams to strengthen quality awareness across the organization

Your Profile

• Degree in engineering, natural sciences, or a comparable technical field
• 3–5 years of professional experience in quality management, ideally within medical devices or a regulated environment
• Strong knowledge of ISO 13485; familiarity with ISO/IEC 27001 and 21 CFR 820 is highly desirable
• Experience with audits and regulatory bodies is an advantage
• Structured, analytical, and solution-oriented working style
• Clear communication skills and a collaborative mindset
• Very good German and English skills

What’s Offered

You will join a modern, stable company that views quality as a strategic advantage rather than a formality. The role offers room to actively shape processes, contribute ideas, and grow within an international environment.

The company provides a competitive compensation package, flexible working options, comprehensive health and wellbeing initiatives, and a range of additional benefits that support work–life balance and long-term security.