QUALITYMANAGEMENT KOORDINATOR (M/W/D)
Core
Strategic leadership in the development and validation of DMS and training tools for in-vitro diagnostics and life science partners, ensuring compliance and supporting key users across the STRATEC Group.
Role type
Senior Quality Management Coordinator (Regulatory & Software Validation)
Builds
Fully automated analysis systems for in-vitro diagnostics and life science
Domain
Medical technology / In-vitro diagnostics (IVD) / Life Science
Deliverable
production ML models
Required skills
EN ISO 13485, FDA GMP, IVD regulation, DMS and training software validation (CSV), strategic thinking, cross-functional team collaboration
Preferred skills
Experience in regulated environments (MedTech, IVD, Pharma), English language proficiency