Regulatory Affairs and Quality Manager

vor 4 Wochen


Stade, Niedersachsen, Deutschland DMG Dental-Material Gesellschaft mbH Vollzeit
Ihre Aufgaben

Wir suchen einen erfahrenen Qualitätsmanager für unsere Abteilung Regulatory Affairs und Quality. Als Teil unseres Teams werden Sie sich um die Konformitätserklärung und CE-Kennzeichnung unserer Produkte kümmern. Dazu gehören die Überprüfung der jeweils gültigen europäischen und nationalen rechtlichen Anforderungen, die Durchführung und Koordination des cross-funktionalen Konformitätsbewertungsprozesses und die Erarbeitung und Überprüfung der rechtlichen Anforderungen an Packmittel und Gebrauchsinformationen.

Ihr Profil

Wir suchen einen Qualitätsmanager mit folgenden Qualifikationen:

  • Abgeschlossenes Studium oder vergleichbare Qualifikation in einem relevanten Bereich
  • Mehrjährige Erfahrung im Qualitätsmanagement von Medizinprodukten, idealerweise im Bereich CE-Konformität
  • Kenntnisse der Anforderungen an technische Dokumentation gemäß EU MDR 2017/745 und Erfahrung im Risikomanagement nach ISO 14971 und ISO 13485
  • Kommunikative Fähigkeiten und Spaß am Austausch mit Schnittstellen und an der Arbeit im Team
  • Sehr gute Deutsch- und Englischkenntnisse
Wir bieten

Wir bieten Ihnen einen sicheren, unbefristeten Arbeitsplatz in einem international agierenden Familienunternehmen. Jeder Mitarbeiter arbeitet täglich für den Unternehmenserfolg, daher beteiligen wir Sie in Form einer Gewinnbeteiligung daran. Um Ihr Privat- und Berufsleben gut miteinander zu vereinbaren, bieten wir Ihnen flexible Gleitzeit. Zu Hause oder von unterwegs arbeiten? Wir bieten Ihnen 30 Tage Urlaub sowie Sonderurlaubstage. Zuschüsse für das Deutschlandticket, Speisen in der Kantine und zur betrieblichen Altersvorsorge. Fahrrad-Leasing über JobRad. Berufliche Weiterbildung ist Ihnen wichtig? Wir bieten Ihnen eine familiäre und kollegiale Arbeitsatmosphäre.



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