Quality Assurance Officer
2 weken geleden
**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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