Mobil 2020

Helena Hjälmefjord  - Curriculum vitae

I have extensive experience within the medical device industry, from Class I to Class III devices, as well as In-Vitro diagnostics. I have a broad experience within Design Control, Usability, Quality Management, Internal and External Auditing, Process validation, ISO 13485, QSR, etc.
I have worked in small national (Swedish) companies as well as large international companies, and held positions in marketing, product development and quality management. In 2013, I started Fjord Consulting, and offer consulting services in medical technology and project management.
I have a degree in biomechanics and a master's degree in product and production development, giving me knowledge and understanding of the products' areas of use. I am also a trained coach, as I believe that employees are the most important resource in a company.
As a person, I am structured, creative and committed. I strive to create order, develop plans with clear deliveries and lead the team to work together. I am driven by challenges, and always try to learn something new in each assignment, and I am happy to share my experiences with others.


2013- ongoing           Fjord Consulting AB. Owner and consultant.
 During these years I have had a number of different assignments within the medical device industry. Detailed information is available on my LinkedIn profile, see link below.
2010-2013         Getinge Sterilization AB. Quality Manager
2009-2010 SemconCaran Medical Life Science. Senior Consultant
2006-2009 HemoCue AB. New Products & Project Manager. 
2001-2006 HemoCue AB. Assistant Marketing Manager.
1995-1998 SIDA. Voluntary work
1988-1995 Various jobs at preschool, schools and being a mother


2020-ongoing                     Munka folkhögskola. Photography education, part-time
2019-2020Munka folkhögskola. KArt scholl, part-time
2016NAMSA. Risk management for medical devices utilizing animal tissues and their derivates 
2016AAMI. Process validation course 
2016BSI Training Academy. Training Lead Auditor ISO 13485 2016
2015Gothia Akademi. Certified coach/NLP
2015BERGO. Medical device usability course
2014University of Manchester. Sterilization of medical devices training
2013-2014Sandholm Associates. Quality manager course
2014Sandholm Associates. Process orientation and process management course
2013ÅF. GMP and GaMP5 course
2013Teknikföretagen. Labor law
2011MGruppen. Introduction to management training
2011AAMI. Quality system requirements and industry practice training
2011AAMI. Corrective and Preventive action/CAPA
2011Trivector LogiQ. Processes mapping and document course
2008Quest Diagnostics. Six Sigma greenbelt training 
2008AAMI. Design control requirements and industry practice course
2007PTK. GGroup and communication
2007CCFL. Advanced project management training
2006-2008University of Halmstad. Master of Engineering in Product and Process Development degree.
1998-2001University of Halmstad. Bachelor of Science in Biomechanical Engineering degree 

Helena Hjälmefjord
Tel +46 722 51 08 69

Helena Hjälmefjord
Tel +46 722 51 08 69

Profil på Linkedin
Fjord Consulting – CV Helena Hjälmefjord