Experience

• 27 years in the international medical device industry in various roles
• 20 years management responsibility in different positions
• 20 years quality management responsibility medical devices (ISO, GMP)
• 10 years product management and marketing experience
• 10 years in business coaching/ organizational development
• Lecturer at SAQ Qualicon
• More than 170 internal and external audits in various roles (ISO 13485 and FDA)

Projects

• Develop QM-Systems according to ISO 13485, MDD/MDR, 21CFR820 (FDA)
• Establish and implement international complaint management and after sales systems
• Internal and supplier audits according ISO 9001, 13485 and FDA requirements
• FDA readiness, compliance and guidance through FDA investigations
• Leadership coaching in various companies
• Lecturing on various topics (ISO 13485, ISO 9001, internal audit, supplier audit)
• Member of the examiner board for quality management and regulatory affairs training courses

Skills

• Medical Devices (diabetes care, pain therapy, treatment of late stage Parkinson’s disease, active devices with and without software, therapeutic devices)
• Diverse manufacturing procedures
• Lean Management
• Quality management (focus on complaint management, post market surveillance, vigilance, CAPA, audit)
• Audit activities (QM system, processes and suppliers)
• FDA Investigation: Responsible for pre and post audit activities including CAPA plans, warning letters and communication to FDA
• Projects to achieve and/or maintain compliance
• Lead and coach change management processes