Group Manager Design Quality Engineering
vor 2 Wochen
Wir suchen eine motivierte und speditive Person an unserem Hauptsitz in Basel als
Ihr Aufgabengebiet- Prozessverantwortung für den effizienten Aufbau, die Umsetzung und Weiterentwicklung von Prozessvalidierungen nach international gültigen Standards
- Verantwortung für die strategische Ausrichtung und Bündelung sämtlicher Prozessvalidierungsaktivitäten der Firma Medartis im Sinne eines strukturierten und dezidierten Projektmanagements
- Verantwortung für sämtliche Prozessvalidierungsprozesse der Firma Medartis, z.B.
- Planung, Durchführung und Aufrechterhaltung von Reinigungsvalidierungen, Sterilisationsvalidierungen
- Planung, Durchführung und Aufrechterhaltung von Reinraumqualifizierungen
- Planung, Durchführung und Aufrechterhaltung von Maschinenqualifizierungen
- Freigabe von Validierungsplänen und -berichten (intern wie extern)
- Freigabe von Qualifizierungsplänen und -berichten (intern wie extern)
- Verantwortung für den Aufbau eines Validierungs-Kompetenz-Teams
- Einführung von Kennzahlen und statistischen Methoden im Bereich Prozessvalidierung
- Begleitung des Design Transfers bei Neuentwicklungen und Änderungen im Rahmen der Prozessverantwortungen
- Mitwirkung bei Prozessrisikoanalysen
- Fachliche Verantwortung für den Transfer von Validierungsaktivitäten und Inhalten
- Teilnahme und Durchführung von internen Audits
- Entwicklung und Ausbau von qualitätsorientierten Schulungen
- Projektleitung bei qualitätsrelevanten Projekten
- Ingenieursstudium oder vergleichbare technische Ausbildung
- Erfahrung in der Leitung von interdisziplinären internationalen Projektteams
- Starke Ausprägung von vernetztem und prozessorientiertem Denken und Handeln
- Mindestens 3 Jahre Erfahrung im Qualitätsmanagement (ISO 13485 und FDA 21CFR820.75) und mindestens 2 Jahre praktische Erfahrung in der Validierung von komplexen Herstell- und Dienstleistungsprozessen in der Medizintechnik
- Deutsch und Englisch in Wort und Schrift
Wir bieten Ihnen eine verantwortungsvolle und abwechslungsreiche Tätigkeit mit hohen Qualitätsanforderungen in einem wachsenden, internationalen Unternehmen mit fortschrittlichen Sozialleistungen.
Über MedartisMedartis ist einer der führenden Hersteller von medizinischen Produkten für die Osteosynthese im Bereich des Gesichtsschädels und der Extremitäten. Medartis hat sich zum Wohle des Patienten verpflichtet, Chirurgen und OP-Personal mit den innovativsten Titanimplantaten und Instrumenten zu versorgen und den besten Service zu bieten.
Für weitere Informationen besuchen Sie bitte unsere Homepage www.medartis.com.
Wir freuen uns auf Ihre vollständige Online-Bewerbung.
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