QA Manager Medical Device

2 weeks ago


Helsingborg, Skåne, Sweden Skånestor Full time

QA Manager Medical Device

Vill du jobba i ett världsledande AI-team och ta banbrytande strålbehandlingsteknologi till nya marknader? Spectronic Medical AB söker en operativ QA Manager. Spectronic Medical är ett medicinteknikbolag som utvecklar AI-baserade bildanalysprodukter som möjliggör träffsäkrare strålbehandling med färre livslånga biverkningar för patienten. Företaget är baserat i Helsingborg och har utsetts till ett av Sveriges 33 ledande unga teknikföretag två år i rad. Spectronic säljer idag sina produkter i bland annat Europa och USA, med pågående arbete för att nå ut över hela världen. Bolaget står därför inför en snabb uppskalning av sin verksamhet.

Dina arbetsuppgifter och ansvarsområden

I rollen som Operativ QA Manager på Spectronic Medical kommer du att arbeta med och dela ansvar för, regulatoriska godkännanden för Spectronics produkter på ett flertal olika marknader. Du kommer vara processansvarig och ansvara för att förnya kvalitetsledningssystemet så att det passar den växande verksamheten och anpassa det mot MDR och QSR. I din roll ingår framtagning, implementering och uppdatering av processdokument (SOP:ar), samt arbete med befintliga och kommande produkters tekniska dokumentation. Du kommer vara involverad i företagets kommande MDR-certifiering och vara drivande i att se till att gällande regelverk och standarder uppfylls för de europeiska och amerikanska marknaderna, och även för framtida marknader.

För att lyckas och trivas i rollen

För att trivas i rollen tycker du att det är stimulerande att arbeta med dokumentation och text, samt att du kan uttrycka dig obehindrat och koncist i tal och skrift på både svenska och engelska. Vi förutsätter att du har mycket god teknisk förståelse. Som person är du logisk, målmedveten och välorganiserad med god förmåga att hantera komplexa uppgifter. Du tar dig an och driver projekt självständigt och kommunicerar tydligt både internt och externt. Du är nyfiken och uppskattar att få använda din kreativitet för att ta dig förbi hinder och utmaningar. Du är en doer med en pragmatisk inställning.

Rekryteringsprocessen

I denna process använder vi oss av löpande urval vilket innebär att vi fortlöpande går igenom din ansökan för att se hur väl din profil matchar kraven för tjänsten. Ser vi dig som en av våra potentiella kandidater kommer vi att kontakta dig för en intervju. I samband med detta får du information om upplägget för intervjun samt övriga steg i processen. Om du inte går vidare i processen blir du informerad om detta senast när vi har tillsatt tjänsten.

Start: Enligt överenskommelse.

Plats: Helsingborg (Hybrid).

För mer information om tjänsten och rekryteringsprocessen är du välkommen att kontakta Maria Gren, Rekryteringsansvarig på SKÅNESTOR, telefon eller via mail:

#J-18808-Ljbffr

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