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Quality Assurance Specialist

2 weeks ago

Allerød Municipality Capital Region of, Denmark Qufora Full time 900,000 - 1,200,000 per year

Vi udvider vores RA/QA-team og søger en engageret og erfaren bred QA Specialist. Du vil spille en afgørende rolle i at sikre, at vores produkter overholder lovgivningsmæssige krav og standarder.

Qufora er en hurtigt voksende virksomhed inden for medicinsk udstyr, der arbejder for at give mennesker med kroniske tarmlidelser et sundt liv. Qufora er beliggende nord for København i Allerød, hvor vi designer og udvikler produkter. Produktionen foregår hos eksterne leverandører i Danmark, Storbritannien og Asien. Du må forvente ca rejsedage om året.

Nøgleansvar og opgaver:

  • Håndtering af klager, afvigelser (NC), korrigerende og forebyggende handlinger (CAPA), risikovurdering og disponeringer, ændringskontrol (CR) og SCARs (leverandør afvigelser).
  • Gennemgå og godkende dokumentation, herunder designkontrol og tekniske filer.
  • Vurdering og godkendelse af leverandører, planlægning og udførelse af leverandøraudits.
  • Deltagelse i eksterne og interne audits.
  • Kontinuerlig forbedring af QMS og kvalitetsprocesser.

Du har med fordel følgende kompetencer:

  • Minimum 3-5 års erfaring inden for kvalitetssikring i en reguleret branche.
  • Erfaring med ISO 13485, MDR og 21CFR820 vil være en fordel.
  • Erfaring med ændringskontrol, afvigelser, klager, CAPA og leverandørkontrolprocesser.
  • Erfaring med interne audits inkl. leverandør audits vil være en fordel.
  • Flydende dansk og engelsk i både tale og skrift.

Som person tager du ansvar og fremstår tydelig og faglig i din kommunikation. Du er i stand til selvstændigt at indsamle, organisere og analysere data, for derefter at konkludere og formidle resultatet i et struktureret format. Du motiveres af at finde pragmatiske løsninger til komplekser problemstillinger og trives med mange bolde i luften.

Qufora tilbyder
 et innovativt miljø med kreative og dedikerede kollegaer som alle arbejder for at forbedre livskvaliteten for vores brugere – og hvor du sammen med dem er med til at sikre produkter i høj kvalitet. En af Qufora's grundlæggende værdier er agilitet og du vil opleve at ord hurtigt omsættes til handling. Du bliver en del af at et højt fagligt RA/QA-team med godt humør og god faglig sparring på tværs af opgaver.

Ansøgning

Send din ansøgning og CV til  Der vil løbende blive indkaldt til samtaler.

Hvis du har spørgsmål, kontakt QA Director Jeanette Skaarup på