Qualitätsmanagementbeauftragte*r AEMP / ZSVA
Core
Ensuring quality management and patient safety in the sterilization of medical devices across multiple hospital locations.
Role type
Quality Management Officer for Medical Device Sterilization
Builds
Sterilization processes and quality assurance workflows for over 100,000 surgeries annually
Domain
Healthcare / Medical Device Sterilization
Required skills
Quality management systems (ISO 13485), regulatory compliance (MDR, MPDG), audit planning and execution, risk analysis, process optimization, stakeholder communication
Preferred skills
Experience in medical device preparation (AEMP), knowledge of hygiene standards
Technologies
DIN EN ISO 13485, MDR, MPDG, KRINKO / BfArM
Responsibilities
Develop and maintain the quality management system, translate requirements into practical standards, plan and conduct internal/external audits, analyze deviations and implement corrective actions, consult on quality goals and regulations
Seniority
Mid-level, hands-on IC