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Quality Assurance Officer
2 weken geleden
Ben jij bekend met ISO 13485 en heb je ervaring met IVDR / MDR? Zo ja, dan hebben wij de perfecte kans voor jou Voor een dynamisch en internationaal opererend bedrijf gevestigd in de provincie Groningen zijn wij op zoek naar een enthousiaste Quality Assurance Officer. Je komt te werken in een hecht team binnen een bedrijf waar kwaliteit, klantgerichtheid en samenwerking centraal staan. Het betreft een baan in de dagdienst voor 32 tot 40 uur in de week. Bij bewezen geschiktheid word je direct in dienst genomen bij onze opdrachtgever.
**Functieomschrijving**
- Onderhouden en verbeteren van het kwaliteitssysteem ISO 13485;
- Implementeren van IVDR (In-Vitro Diagnostic Regulation) systeem;
- Bijhouden van nieuwe wet
- en regelgeving;
- Aanpassen van processen, procedures en documenten;
- Klachtafhandeling;
- Uitvoeren van interne audits;
- Contact met leveranciers.
**Functieprofiel**
- Afgeronde HBO of WO opleiding;
- Je hebt ervaring met ISO 13485 is een pré;
- Je hebt kennis van ISO 14971;
- Je hebt ervaring met IVDR of MDR (Medical Device Regulation) is een pré;
- Je hebt een goede Nederlandse en Engelse taalbeheersing in woord en geschrift;
- Je kan goed plannen en gestructureerd werken;
- Je neemt graag initiatief en bent nauwkeurig.
Soort dienstverband: Fulltime
Rooster:
- Dagdienst
- ma-vr
Secundaire arbeidsvoorwaarden:
- Pensioen
- Reiskostenvergoeding
Werklocatie: Fysiek
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