QA/RA

Brainreader Copenhagen Full-time
Salary Competitive
Kommer du med en ingeniør baggrund fra sundhedsteknologi eller er du allerede en erfaren QA/Regulatory Assurance-profil fra medicinal branchen?​ Og er du klar til en selvstændig rolle i en mindre organisation, som med deres innovative software gør en forskel i hvordan sygdomme i hjernen, såsom Alzheimers, diagnosticeres? Så er du måske den nye QA/RA Engineer til Brainreaders team, der med et dedikeret og entreprenant mindset forfølger visionen om at levere avancerede sundhedsløsninger til alle.

Ejerskab for kvalitet af design, standarder og compliance

Med ​reference til Senior SW Development and Project Manager tager du ejerskab for at opnå den mest effektive og nøjagtige kvalitetssikring. Dette indebærer operationel eksekvering ​af aktuelle QA-processer samt analyse for at identificere processer og områder, der kan optimeres. Ligeledes indgår overvågning af software udviklingsprocesser for at sikre kvalitet af design, standarder og compliance med ISO13485, HIPAA og GDPR.

Du identificerer og implementerer i samarbejde med organisationen og eksterne konsulenter valide software test strategier og best practices for beskyttelse af data i henhold til EU (CE, MDD/MDR) og USA regulativer (FDA). Dine ansvarsområder vil omfatte følgende:

●  Sikre compliance til standarder i overensstemmelse med lovgivning og ISO 13485/62304

●  Definere kvalitetskrav, som understøtter udvikling og dokumentation af features og software design med henblik på USA leverancer

●  Foretag interne kvalitets audits og koordinering af eksterne audits

●  Forestå regelmæssig træning og udvikling af organisationen

●  Sikre at QA afvigelser tilstrækkeligt rapporteres, dokumenteres og løses i

overensstemmelse med interne procedurer.

Arbejdsplads: Frederiksberg

Workplace: Frederiksberg, Copenhagen


For more information or questions please contact us at anita@koldpartners.com or phone number 24847205

Perks and benefits

This job comes with several perks and benefits

Flexible working hours
Flexible working hours

Time is precious. Make it count. Morning person or night owl, this job is for you.

Social gatherings
Social gatherings

Social gatherings and games; hang out with your colleagues.

Near public transit
Near public transit

Easy access and treehugger friendly workplace.

Pension plan
Pension plan

We take care of you, even when you are old and wrinkly.

Maternity / paternity leave
Maternity / paternity leave

Kids are the future, go spend time with them.

Healthcare insurance
Healthcare insurance

Break a leg! Seriously, we got you covered in our company healthcare plan.

See all 12 benefits

Working at
Brainreader

Brainreader is one of the most exciting MedTech companies in Denmark thanks to the Neuroreader® software, an assessment tool for healthcare professionals. Neuroreader® helps improve the lives of millions of patients with brain disorders by assisting the medical staff in discovering otherwise overlooked diseases and ensuring patients quick and correct medical treatment. Through its work, Brainreader aims to provide quantifiable and accurate insight into the brain. By increasing the use of medical image processing software, Brainreader is providing healthcare professionals around the world with access to structural MRI's in a faster, more specific and more objective way.

Read more about Brainreader

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