Andreas Becker

a.beckernoSpam@axxos.noSpamch

  • Mechanical Engineer (major: polymer technique)
  • Executive MBA (major: international management / Asia)
  • Lead Auditor ISO 13485:2016 

Head of Quality Management Services
Senior Consultant at Axxos GmbH since 2012

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)

My personal scrabble