Vibeke Bach-Hansen

Vibeke Bach-Hansen holds an AP Degree in Chemical and Biotechnical Science from Zealand – Academy of Technologies and Business. She has more than 10 years of experience and has throughout her career worked with quality control and quality assurance within analytical laboratories and Design Control within medical devices.

Previously, Vibeke worked as the Quality Responsible in an ISO 17025 accredited laboratory and as a QA Engineer in an ISO 13485 certified company where maintenance and raising awareness of the quality system was the primary task. She is sharp within ISO 13485 and internal auditing in precisely this standard.

Vibeke was also responsible for the Change Control process and supported the NC / CAPA processes with her positive and solution-oriented approach to the workflows.

She has also worked as a Design Control Specialist with class IIb medical devices where management and preparation of design control/technical documentation were the focus area. As a Design Control Specialist Vibeke has achieved extensive knowledge of the different development stages as well as the regulatory requirements that apply to the development of medical devices.

“I am a positive and pragmatic person who enjoys a structured everyday life but can also easily adapt to ad hoc tasks. I have what it takes to ensure progress in my tasks, and I take great pride in delivering on time, while maintaining a high-quality level. I believe that we will find a solution together and can have a constructive dialogue about the path to the common goal. I challenge processes and am curious about why we do as we do – and whether it is still the most optimal way to do it”