Helena Hjälmefjord

Helena Hjälmefjord is an experienced medical device trainer currently working at Medical Device HQ since November 2022, specializing in Design Control, Requirements Engineering, and Process Validation. Helena has been a Medical Device Trainer and Project Leader at Fjord Consulting AB since June 2013, overseeing regulatory compliance for new medical device designs and leading various projects, including office relocations and ISO compliance updates. Previous roles include Quality Manager and Chief Project Manager at Getinge Sterilization AB, and New Products & Project Manager at HemoCue AB, showcasing a solid background in product development and project management within the medical device sector. Helena holds a Master's degree in Product Development and has completed several courses in quality management.