Lena K.

Lena K. is a Quality Engineer with extensive experience in quality assurance and regulatory compliance within the medical device and pharmaceutical sectors. Currently employed at Semcon since February 2022, Lena previously served as a QA Product Development Engineer at Mölnlycke from April 2022 to June 2023, focusing on design control and risk management. Earlier roles include Quality Specialist at Oriola Corporation, where Lena was responsible for the validation process and supplier audits, and Quality Manager via ÅF at Wellspect HealthCare, overseeing customer complaints and document control. Lena has also contributed as a consultant for AFRY and ALTEN Sweden, specializing in the pharmaceutical division and conducting a master's thesis on structural dynamics in collaboration with Cochlear Bone Anchored Solutions AB. Lena holds a Master's degree in Biotechnology from Chalmers University of Technology and a Bachelor’s degree in Biomedical Engineering from Gachon University, supplemented by an exchange program at the University of Arizona. Additionally, Lena is an EIT Digital Alumni with a fellowship in Digital Medical Devices.