Qualitätsmanager (m/w/d),Wiesbaden,Magdeburg
Core
Ensure and develop the quality management system for in-vitro diagnostic reagents and analysis systems, ensuring compliance with international standards and regulations.
Role type
Quality Management Manager (In-vitro Diagnostics)
Builds
Quality management processes and documentation for medical devices/IVD
Domain
Healthcare / In-vitro Diagnostics / Medical Devices
Required skills
Quality management system implementation, internal and external audit management, regulatory compliance (ISO 9001, ISO 13485, IVDR), process improvement, corrective and preventive action handling, document control, training delivery, data analysis
Preferred skills
Experience with new IT systems for QM, travel readiness
Technologies
ISO 9001, ISO 13485, IVDR (Regulation (EU) 2017/746)
Responsibilities
Plan and conduct internal audits; prepare for and participate in external audits; support data preparation and management reviews; manage documents and records; develop and document process descriptions; handle corrective and preventive actions; identify and address quality deviations; implement regulatory requirements; conduct QM-related training; analyze cross-departmental processes for compliance
Seniority
Mid-level, hands-on IC