Qualitätsmanager Produkt- und Prozessentwicklung (m/w/d)

About this job

For one of our clients near Freiburg, we are looking for a Quality Manager Product and Process Development (m/f/d).

In a modern work environment, our client supports the work of doctors worldwide through innovative products and solutions.

The company's goal is to increase patient safety and sustainably improve clinical outcomes with high-quality and advanced products. Numerous patents, an international sales network, and subsidiaries in the USA and Asia underscore the global orientation and strong innovative strength.

Our client offers a dynamic and future-oriented work environment with room for initiative, further development, and exciting projects.

Responsibilities:

• Responsibility for the further development, maintenance, and continuous optimization of the QM system according to ISO 13485, MDR, and MDSAP
• Independent project management for the further development of existing processes with regard to applicable regulations
• Organization and control of the CAPA process, including support and follow-up of measures as the central project manager
• Evaluation and presentation of key performance indicator management
• Planning, execution, and follow-up of internal and external audits
• Interface management with development, product management, production, and regulatory affairs to ensure product conformity
• Participation in development projects, especially in risk management (FMEA)

Benefits:

• Flexible working hours
• Home office option
• Company pension plan
• Health management
• Hansefit membership
• JobRad or JobRoller

Profile:

• Completed technical or scientific degree (e.g., medical technology, electrical engineering) or a comparable technical qualification (Technician)
• Several years of professional experience in a regulated environment
• Initial experience in project management in the medical device sector
• Sound knowledge of relevant standards and regulations: ISO 13485, ISO 14971, MDR, MDSAP
• Experience with FMEA, CAPA management, and process validation
• Technical understanding - especially in electrical engineering is an advantage
• Very good German and good English skills Benefits: Pension Plan MinSalary: 70000 MaxSalary: SalaryCurrency: EUR Remote Model: Hybrid Country Code: de