Hèlen Therese Kalfjøs

Hèlen Therese Kalfjøs has extensive work experience in various roles related to quality assurance and regulatory affairs. Hèlen Therese is currently serving as the Chief Quality Officer at Sensio since May 2023. Prior to this, they worked as the Head of Quality Assurance & Regulatory Affairs at RemovAid from June 2021 to May 2023.

Before joining RemovAid, Hèlen worked as a Quality Manager at Luzmon Medical AS from February 2020 to June 2021. In this role, they were responsible for developing and revising QMS procedures and policies to ensure compliance with relevant regulations. Hèlen Therese also conducted training sessions to ensure employee understanding and compliance.

Hèlen also has experience as a Senior Consultant at Malsen Medical from May 2019 to January 2020. Prior to that, they worked at LINK Medical Research as a Senior Medical Device Manager and Senior Regulatory Associate Medical Device from January 2018 to May 2019 and July 2017 to December 2017, respectively.

Before their roles at LINK Medical Research, Hèlen served as a QA Engineer at GE Healthcare from August 2012 to July 2017. Hèlen Therese was responsible for QA representation in the design and development of probe engineering and the entire manufacturing facility. Hèlen Therese also served as the site CAPA leader.

Prior to GE Healthcare, Hèlen worked as a QA Manager and QC Manager at NorSun from April 2011 to August 2012 and November 2007 to April 2011, respectively. In these roles, they were responsible for maintaining the company's QMS (ISO 9001), developing procedures and instructions, and managing the company's laboratory.

Hèlen began their career as a Laboratory Engineer at NILU from June 2004 to February 2005 and at Kraft Foods Norge AS from March 2003 to June 2004. Hèlen Therese also worked briefly as an Operator at ScanWafer in November to December 2002.

Hèlen Therese Kalfjøs completed their education in the field of Chemistry. Hèlen Therese earned a Bachelor's degree in Analytical Chemistry from OsloMet – Oslo Metropolitan University during the period from 1997 to 2000. Later, they pursued a Master's degree in Chemistry from the University of Wollongong, which they obtained between 2000 and 2001. In addition to their academic achievements, they also obtained a certification as a Certified ISO 13485:2016 Lead Auditor from the Kelmac Group in October 2018.