Dr. Chen-Ket Chai, PhD MSc

Experience

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  Fraunhofer-Gesellschaft

  Jan 2005 - Feb 2006

  Research Assistant

  Internship, working on the characterisation of long-term ECG electrodes

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  Fraunhofer-Gesellschaft

  Jan 2007 - Jan 2007

  Research Assistant

  Diploma thesis, studying the chemical stability of nano-porous aluminium-oxide membranes using flow-injection analysis

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  LZH - Laser Centre Hannover

  Apr 2008 - Jan 2010

  Research Assistant

  Research Assistant and Master student, working on a project regarding the treatment of age-related far-sightedness using femto-second laser-pulses

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  Eindhoven University of Technology

  Jan 2010 - Jun 2015

  Research scientist

  Mechanical properties of atherosclerotic plaques

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  University of Oxford

  Jan 2010 - Jan 2010

  Academic Visitor

  Visiting Scholar funded by the Leonardo-Da-Vinci-Programme, studying the biomechanic of eye lenses

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  Fresenius Medical Care

  Jul 2015 - Nov 2022

  As Teamleader responsible for quality management and quality assurance at the Xenios sites in Heilbronn and Reutlingen, I supervise a team of about 15 engineers and quality managers. In my team we are responsible for change management, CAPA management, complaint investigation, documentation control, quality management, audit management, supplier management, quality control, equipment qualification and validation according to ISO 13485, 21CFR820. I supervise the newest haemodialysis machine of Fresenius, the 6008, which was launched in 2016. I am responsible for product safety, technical documentation according to MDR, risk management and market surveilance of the 6008.

  • Team Leader Quality Management and Quality assurance

    Apr 2020 - Nov 2022

  • Product Center Manager

    Jul 2015 - Jan 2020
• 

  Greiner Bio-One International

  Jan 2022 - now

  Director Quality Management

  As Director of Quality Management with direct reporting line to the managing director, I am member of the local management and also appointed as Person Responsible for Regulatory Compliance and Management Representative for Greiner Bio-One in Germany. The responsibilities include• Ensuring that the requirements for the quality management system according to (EN) ISO 13485, ISO 9001, 21 CFR 820 and that the Taiwan requirements including the necessary processes are effectively implemented and maintained • Reporting on the performance of the quality management system to the management • Promotion of awareness within the company of legal requirements and customer demandsAs Director Quality Management I am also responsible for quality management and quality assurance at Greiner Bio-One, In my team we are responsible for Change management, CAPA management, complaint investigation, documentation control, quality management, audit management, supplier management, quality control, equipment qualification and validation according to ISO 9001, ISO 13485, 21CFR820. Weniger anzeigen