Experienced Project Leader with a 15+ years track record at a renowned U.S. MedTech enterprise, passionate about digitalization of quality management processes

• Dr.-Ing. Industrial Engineering
• Successfully lead New Product Introduction and Lifecyle Management projects / sub-projects for several class II and class II medical devices
• SME in the areas of EU MDR, ISO 13485, Equipment Qualification (IQ), Process Validation (OQ/PQ), Risk Management (ISO 14971), Design Control, Corrective and Preventive Actions, Non-Conformance Management
• 20+ national and international publications in the areas of Work Organization and Multi-Project Management
• Six Sigma Black Belt, Lean Green Belt, MTM, FPX (Johnson & Johnson Flawless Project Execution)
• Founder and CEO at Tracion Solutions GmbH i.G.