[et_pb_section fb_built=”1″ admin_label=”About Us” _builder_version=”4.20.4″ background_color=”#f2ece9″ min_height=”870.4px” custom_padding=”18px|0px|18px|0px|true|false” locked=”off” global_colors_info=”{}”][et_pb_row column_structure=”1_2,1_2″ _builder_version=”4.20.4″ min_height=”846.4px” custom_padding=”47px||41px|||” global_colors_info=”{}”][et_pb_column type=”1_2″ _builder_version=”4.20.4″ custom_padding=”0px||||false|false” global_colors_info=”{}” custom_padding__hover=”|||”][et_pb_image src=”https://fjordconsulting.se/wp-content/uploads/2023/06/Fjord-Consulting-Medicinteknik-Helena-Hjalmefjord-scaled.jpg” title_text=”Fjord Consulting Medicinteknik Helena Hjälmefjord” align_tablet=”center” align_phone=”center” align_last_edited=”on|desktop” _builder_version=”4.20.4″ min_height_tablet=”” min_height_phone=”” min_height_last_edited=”on|desktop” height_tablet=”405px” height_phone=”405px” height_last_edited=”on|phone” custom_margin=”|33px||||” custom_margin_tablet=”-160px|||” custom_margin_phone=”0px|||” custom_margin_last_edited=”off|desktop” animation_style=”slide” animation_direction=”bottom” animation_intensity_slide=”5%” box_shadow_style=”preset3″ box_shadow_vertical=”70px” box_shadow_blur=”80px” box_shadow_spread=”-60px” global_colors_info=”{}”][/et_pb_image][/et_pb_column][et_pb_column type=”1_2″ _builder_version=”4.20.4″ custom_padding=”6%|||0%|false|false” global_colors_info=”{}” custom_padding__hover=”|||”][et_pb_text _builder_version=”4.20.4″ _module_preset=”default” text_font=”Poppins||||||||” text_font_size=”10px” text_letter_spacing=”2px” custom_margin=”||2px|||” global_colors_info=”{}”]
FJORD CONSULTING AB
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MEDICINTEKNIK
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Helena Hjälmefjord
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Jag har en gedigen kunskap och lång erfarenhet av att arbeta enligt de olika medicintekniska regelverk, krav och standarder som finns. Jag har varit involverad i utvecklingen av ett flertal medicintekniska produkter, klass I-III, från idé till att de är godkända att säljas av myndigheter, både i EU och USA. Jag har arbetat i små nationella företag och stora internationella företag, där jag har haft roller som projektledare, produktchef samt kvalitetschef. 2013 startade jag Fjord Consulting, och erbjuder konsulttjänster inom medicinteknik och projektledning.
Jag har en examen i biomekanik samt en magister i produktionsutveckling och strategisk design, vilket gör att jag har en förståelse för produkternas användningsområden. Jag är även utbildad coach, då jag anser att de anställda är den viktigaste resursen i ett företag.
Som person är jag strukturerad, kreativ och engagerad. Jag trivs som bäst när jag kan skapa ordning och reda, ta fram planer med tydliga leveranser samt leda teamet och arbetet framåt. Jag drivs av utmaningar, och försöker alltid lära mig något nytt i varje uppdrag, samtidigt som jag gärna delar med mig av mina erfarenheter till andra.
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+46 722 51 08 69
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Yrkeserfarenhet
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2013-nuvarande
Fjord Consulting AB. Ägare och konsult
Fjord Consulting AB. Ägare och konsult. Under dessa år har jag haft ett flertal olika uppdrag, nationellt och internationellt.
Detaljerad information finns på LinkedIn.
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2010-2013
Getinge Sterilization AB
Kvalitetschef
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2009-2010
SemconCaran Medical Life Science
Senior Consultant
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2006-2009
Hemocue AB
Assistant project manager
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2001-2006
Hemocue AB
New Products & Project Manager
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1995-1998
SIDA
Volontärarbete
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1988-1995
Diverse anställningar på förskola, skola samt mammaledig
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Utbildning
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2023
MedicalDeviceHQ
Introduction to the Medical Device Requirements Engineering
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2022
MedicalDeviceHQ
Project Management for Product Development of Medical Devices
Risk Management for Medical Devices and ISO 14971:2019
Design Control for Medical Devices
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2016
NAMSA
Risk management for medical devices utilizing animal tissues and their derivates
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2016
AAMI
Process validation course
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2016
BSI Training Academy
Training Lead Auditor ISO 13485 (5 dagar)
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2015
Gothia Akademi
Diplomerad coach/NLP
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2015
BERGO
Medical device usability
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2014
University of Manchester
Sterilization of medical devices
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2013-2014
Sandholm Associates
Kvalitetschefskurs
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2014
Sandholm Associates
Processorientering och processledning
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2013
ÅF
GMP och GaMP5 Grundkurs
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2013
Teknikföretagen
Arbetsrätt
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2011
MGruppen
Introduction to management
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2011
AAMi
Quality system requirements and industry practise
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2011
AAMi
Corrective and Preventive action/CAPA
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2011
Trivector LogiQ
Kartlägga och dokumentera processer
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2008
Quest Diagnostics
Six Sigma greenbelt training
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2008
AAMI
Design control requirements and industry practise
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2007
PTK
Grupp och kommunikation
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2007
CCFL
Advanced project management training
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2006-2008
Högskolan i Halmstad
Magisterexamen i teknisk produkt- och produktionsframtagning
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1998-2001
Högskolan i Halmstad
Högskoleingenjörsexamen i biomekanik
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Kontakta oss om ni vill veta mer
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Fjord Consulting är ett familjeföretag med konsulter verksamma inom medicinteknik, vindkraft, anläggning och projektledning.
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