Susanne Wyss-Lanz

s.wyss-lanznoSpam@axxos.noSpamch

  • Chemist
  • Advanced training as business coach, product and project manager
  • Several Quality Management trainings (Europe / USA)


Head of Quality Management Services
Senior Consultant at Axxos GmbH since 2021

Experience

  • 25 years in the international medical devoce industry in various roles
  • 18 years management responsibility in different positions
  • 18 years quality management responsibility medical devices (ISO, GMP)
  • 10 years product management and marketing experience
  • 8 years in business coaching/ organizational development
  • More than 150 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)
  • Expert examiner 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

My personal scrabble

is in production yet...