Chen-Ket Chai

Director Quality Management @Greiner Bio-One International

Frickenhausen, DE

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.

Hochschule Anhalt

Diplom-Ingenieur (FH), Biomedical/Medical Engineering

Leibniz Universität Hannover

Master of Science (M.Sc.), Biomedical/Medical Engineering

Eindhoven University of Technology

Doctor of Philosophy (Ph.D.), Biomedical/Medical Engineering