Head Of Quality Management (M/W/D) Medical Devices

Our client offers specialized equipment and cutting-edge technology solutions for emergency services and other mission-critical sectors. There are over 450 people who meet the highest demands of rescuers from more than 75 countries. Here, not only innovative products are created but also successful careers. They always realize that only those who feel comfortable are motivated and can always be inspired anew.

• Manage both the technical and disciplinary aspects of the QM team of 3-6 people, expanding the ISO13485 QM system to meet international requirements like FDA QSR 820, SOR/98-282.

• Organizing external Quality Management audits, planning and executing ISO 13485 FDA QSR 820 audits, and ensuring compliance with QM system processes and product-specific standards.

• Collaborate with relevant divisions, departments, and process owners to continuously improve QMS.

• You possess strong expertise in QM systems (including MDSAP, FDA QSR 820, DIN EN ISO 13485:2016, MDR Article 10) and project management, particularly in implementing.

• You also have experience in active Medical Devices, risk analysis, FMEA, quality methods, CAPA, root cause analysis, and problem-solving.

• Leadership experience, analytical thinking, abstract reasoning, meticulousness, and technical understanding of active Medical Devices are notable traits.

• Your profile is enhanced by a university degree in a technical field (e.g., medical technology, electrical engineering, mechanical engineering) or extensive experience in QM/RA in medical technology.

• Home office availability for flexible work arrangements.

• Kindergarten / nursery allowance support for employees with children.

• Company pension scheme offering long-term financial security.

Daria Panasenko

Recruitment Specialist

E-Mail d.panasenko@brownianmotion.eu

Brownian Motion GmbH