Aktuelle Jobs im Zusammenhang mit Quality Engineer in der Herstellung Medizintechnik - Chur - gloor&lang AG


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Quality Engineer in der Herstellung Medizintechnik

vor 5 Monaten


Chur, Schweiz gloor&lang AG Vollzeit
Prozess Change Management - Testvalidierung - Dokumente

Unser Kunde ist ein innovativer Hersteller von anspruchsvoller Medizintechnik.
Sie sind eine initiative und analytische Fachperson mit Erfahrung in QA Prozessen in Zusammenarbeit mit der Produktentwicklung und/oder Prozessentwicklung.

Hauptaufgaben:

  • Überprüfung und Freigabe der Teststrategie, Testpläne und Testberichten bei der
  • Mitarbeit und Freigabe von qualitätsrelevanten Dokumenten im Produktionsumfeld.
  • Umsetzung von Produkt- und Prozessänderungen und deren Verifizierungen resp. Validierungen
  • Dokumentenerstellung – Prüfung und Freigabe
  • Compliance nach ISO 13485 und 21 CFR Teil 11 und 820
  • CAPA Koordination von Verbesserungen und Korrekturmassnahmen
  • Unterstützung bei internen und externen Audits
  • Permanente Optimierung der QA Prozesse und Dokumentation in der betreffenden Herstelleinheit

In dieser Funktion arbeitest du eng mit Teams aus der Produkt- und Prozessentwicklung zusammen. Du bist der Experte für Qualität und berätst die Teams entsprechend Anforderungen:

  • Technische oder naturwissenschaftliche Ausbildung
  • Erfahrung in einer Quality Funktion in einem herstellenden Betrieb
  • Erfahrungen aus der Medizintechnik Klasse I bis III
  • Kenntnisse Regularien: ISO 13485, MDD, MDR, 21 CFR Part 820
  • Erfahrung bei der Prozessvalidierung (IQ/OQ/PQ)
  • Kenntnisse QM Techniken wie Ishikawa, 5 why, Fehlerbaum, 8D
  • Sehr gute Deutsch- und Englischkenntnisse in Wort und Schrift

Du trittst sicher auf und hast schon Meetings moderiert. Gesucht werden initiative und kommunikative Persönlichkeiten mit Hands-on Mentalität und kundenorientierte Lösungsansätze.