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Product Quality Engineer

https://www.baxter.com/ Logo

Baxter

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Standort:
Germany , Saalfeld

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Jobbeschreibung:

This is where you make a difference in our patients’ safety. As a member of the Baxter Quality team, you will play an essential part in our mission of saving and sustaining lives. Quality is important throughout the entire product lifecycle and works collaboratively with all areas of the organization. Because Quality touches everything Baxter does, a role in Quality provides many opportunities for growth, learning and a successful career that has a daily impact on people’s lives.

Verantwortlichkeiten:

  • Mitarbeit im Produktentwicklungsprozess, insbesondere bei der Erstellung und Pflege von Qualitätsdokumentationen (z. B. Design History File)
  • Mitwirkung bei Risikoanalysen für Medizinprodukte in Zusammenarbeit mit der Entwicklungsabteilung
  • Unterstützung bei FMEA-Aktivitäten in Entwicklung und Produktion
  • Mitarbeit im Produktänderungsprozess, inklusive Bewertung von Anforderungen, Umfang und Validierung von Änderungen
  • Planung, Durchführung und Bewertung von Baugruppen- und Produkttests
  • Erstellung, Pflege und Weiterentwicklung von Prüfplänen (Werkerselbstprüfung und Endprüfung) über den gesamten Produktlebenszyklus
  • Definition und Validierung von Prüfmitteln
  • Mitwirkung bei der Bearbeitung eskalierender Qualitätsprobleme in Zusammenarbeit mit internen Schnittstellen und Lieferanten
  • Dokumentation und Weiterleitung von Meldungen zu Risiken, Fehlfunktionen oder Vorkommnissen gemäß den gesetzlichen Vorgaben für Medizinprodukte
  • Sicherstellung der Einhaltung nationaler und internationaler gesetzlicher Anforderungen sowie relevanter Normen im Bereich Medizinprodukte

Anforderungen:

  • Abgeschlossene technische oder medizintechnische Ausbildung mit entsprechender Zusatzqualifikation
  • Abgeschlossenes Hochschulstudium (Bachelor oder vergleichbar), bevorzugt im medizintechnischen oder technischen Bereich
  • Mehrjährige relevante Berufserfahrung im Qualitätsumfeld, idealerweise in der Medizinprodukteindustrie
  • Kenntnisse in Qualitätsmethoden und -werkzeugen wie PDCA, 8D- und A3-Methodik, 5 Why / Ishikawa, FMEA, Pareto-Diagramm und Korrelationsdiagramm
  • Sicherer Umgang mit technischen Dokumentationen und Qualitätsprozessen
  • Strukturierte, sorgfältige und eigenverantwortliche Arbeitsweise
  • Erfahrung in der strukturierten Darstellung, Zusammenfassung und Präsentation von Analyseergebnissen und Handlungsempfehlungen
  • Teamfähigkeit sowie Kommunikationsstärke im Austausch mit Entwicklung, Produktion und Lieferanten
  • Verhandlungssicher in Englisch und Deutsch in Wort und Schrift
Was wir biete:
  • Unterstützung für Eltern
  • Fort- und Weiterbildung / berufliche Entwicklung
  • Mitarbeitergesundheit und Wohlbefinden
  • bezahlter Urlaub
  • 2 Tage im Jahr für ehrenamtliche Arbeit
  • interessante berufliche Perspektiven
  • kooperatives Arbeitsumfeld
  • leistungsorientiertes Entgelt
  • flexible Arbeitszeitmodelle
  • Programme zur Weiterbildung, Gesundheitsförderung und betrieblichen Altersvorsorge

Zusätzliche Informationen:

Job veröffentlicht:
16. April 2026

Job-Link teilen:

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