Quality Manager (m/f/d) Medical Technology (Specialist - Quality Assurance/Management)

As a Quality Management Manager (m/f/d), you will take on a central role in ensuring and further developing the quality management system in a regulated medical technology environment. You will act as an interface between management, specialist departments, and external partners and ensure regulatory compliance.

• Maintenance, care, and continuous development of the quality management system according to DIN EN ISO 13485
• Ensuring the company's conformity with regulatory requirements according to EU-MDR (2017/745)
• Planning, implementation, documentation, and follow-up of internal audits as well as support for external audits and inspections
• Creation of regular management reports on the effectiveness of the QMS, including KPI tracking, deviation analyses, and action tracking
• Support in the creation, maintenance, and release of quality-relevant documents (SOPs, processes, forms, guidelines)
• Advising specialist departments on quality- and regulatory-relevant issues
• Implementation and coordination of data protection management in close cooperation with the external EU-DSGVO officer
• Training of employees on QM-relevant topics (ISO 13485, MDR, data protection)
• Support in CAPA, deviation, and risk management processes
• Participation in continuous improvement processes (KVP) within the company

What you bring to the role

• Several years of demonstrable experience in the establishment, maintenance, and further development of quality management systems in a regulated environment (ideally medical technology)
• Very good knowledge of DIN EN ISO 13485 as well as a fundamental understanding of the EU-MDR
• Experience in the planning and implementation of internal audits
• Structured, systematic, and independent way of working
• High communication skills and a confident appearance towards management, authorities, and auditors
• Very good English skills in speaking and writing
• Very good knowledge of common MS-Office applications
• Pragmatist mindset: solution-oriented, strong in implementation, hands-on

Nice-to-have

• Experience in data protection management / cooperation with external data protection officers
• Auditor qualification (internal / external)
• Experience in the establishment or optimization of QMS structures in SMEs or high-growth companies
• Experience in project or interim environments

What awaits you

• Responsible key role with high visibility within the company
• Direct influence on regulatory compliance and company quality
• Cooperation with management, specialist departments, and external bodies
• Dynamic environment in medical technology with a long-term perspective
• Attractive project or contract models

Additional information: Requirements for the applicant: Basic knowledge: Quality management, energy management systems, CE marking, penetrant testing, minimum standards for medical devices according to DIN EN ISO 13486