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

Helena Hjälmefjord
Tel +46 722 51 08 69
hhj@fjordconsulting.se

