Experience

• > 20 years in medical device industry
• > 10 years biomechanical testing
• 8 years operative management of biomechanical test site incl. employees
• > 10 internal audits ISO 13485
• Lecturer at SAQ Qualicon, Olten “Quality management in medical technology”, lectures document control and traceability 

Projects

• Clean room conception and validation in Europe and China
• Qualification and validation of production equipment and processes
• Validation of surface treatment and cleaning processes
• Qualification of measuring methods (MSA)
• Process capability studies
• External management of quality management systems according to ISO 13485
• Internal audits according to ISO 13485 of entire companies including the development process in German and English
• Planning, installing and running a biomechanical test site 

Skills

• Tribology of artificial joints (hip, knee, shoulder)
• Measurement techniques: CMM (tactile), roughness (non-tactile), microscopy
• General fatigue testing of class III products (servo-hydraulic load frames, specific ISO 7206-2/4/6/8 and ISO 14243
• Abrasive wear testing and calculation
• Quality Assurance (Qualification, Validation, GxP) 
• Qualification and validation of equipment, production and measuring processes 
• Quality Management System documentations according ISO 13485 and FDA
• Materials (metals and plastics)
• Knowledge of the Chinese culture and basics in Chinese language (HSK II)