Manufacturing Quality Engineer
vor 1 Monat
Als Manufacturing Quality Engineer (m/w/d) unterstützen Sie bereichsübergreifend die Entwicklung und Produktion innovativer Medizinprodukte zur Herz- und Lungenregeneration.
Gehen Sie Ereignissen methodisch auf den Grund und helfen Sie uns verantwortungsvolle Qualitätsentscheidungen zu treffen.
Spannende Aufgaben warten auf Sie:
- Als Quality Engineer leiten Sie das Non-Conformity Management über die gesamte Wertschöpfungskette
- Sie verantworten die Einhaltung unserer SOPs und externen Regularien im Änderungsmanagement, sowie in der Prozessqualifizierung
- Sie koordinieren Ursachenanalysen in multidisziplinären Teams und wenden dabei Ihre Methodenkenntnisse an
- Durch Ihr proaktives Handeln sorgen Sie dafür, das kontinuierliche Verbesserungen an Prozessen und Produkten umgesetzt werden
- In Ihrer Tätigkeit führen Sie eigenverantwortlich interne Audits
Ihr Profil:
- Bachelor oder Master in Naturwissenschaften oder Ingenieurwissenschaften mit technischem Schwerpunkt oder Techniker mit Berufserfahrung
- Berufserfahrung im Engineering und/oder Quality Management in der Medizintechnik (oder Automotive Industry) wünschenswert
- Praktische Kenntnisse der FDA QSR, ISO 13485 und ISO 14971
- Erfahrung in der Anwendung Statistischer Methoden
- Kommunikativ (Deutsch und Englisch), durchsetzungsstark
- Spaß an der Teamarbeit in einem innovativen und globalen Arbeitsumfeld
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