Quality Assurance Manager

vor 4 Wochen

Bern, Schweiz CTC Resourcing Solutions Vollzeit

**Das Life Science Karriere Netzwerk**

CTC vereint Experten aus den Bereichen Life Sciences und Personalwesen. Wir helfen Unternehmen die besten Talente zu finden und zu binden. Unsere Kandidaten begleiten wir in ihrer beruflichen Entwicklung und finden für sie zu ihrer jeweiligen Lebenssituation passende Karrieremöglichkeiten.

Für unseren Kunden, ein Schweizer MedTech Unternehmen im Berner Mittelland, suchen wir eine(n)

**Quality Assurance Manager MedTech (5430)**

**80-100%**

Ihre Hauptaufgaben
- Teilnahme, Überwachung und Unterstützung von Entwicklungsprojekten der Produktion und anderen Bereichen, damit alle relevanten Gesetze, Vorschriften und Spezifikationen wie beispielsweise cGMP, ISO 13485, CFR Part 820 und FDA Guidelines eingehalten werden
- Betreuung und Umsetzung der täglichen Aufgaben der Quality Assurance; insbesondere Produkt-Freigaben, Änderungswesen, Qualitätsdokumentationen sowie Bearbeitung von Abweichungsmeldungen
- Prüfen und Freigeben der in Entwicklungs
- und Industrialisierungsprojekten anfallenden Abläufe und Dokumente (z.B. Design Verifizierung / Qualifizierungs
- und Validierungsdokumenten)
- Mitarbeit bei internen, Kunden-, Behörden
- und Lieferantenaudits
- Selbstständiges Arbeiten in multidisziplinären Teams
- Teilprojektleitung in zugewiesenen Projekten

Ihr Profil
- Abgeschlossene technische oder naturwissenschaftliche Weiterbildung (HF, FH oder vergleichbar)
- Erfahrungen im Projektmanagement
- Weiterbildung im Bereich Qualitätswesen
- Vertiefte Kenntnisse im Bereich Qualitätssicherung/cGMP
- Versierter Umgang mit SAP, Quality Tools (z.B. FMEA, SPC usw.) und MS-Office Tools (Excel, Power Point usw.)
- Gute Deutsch
- und Englischkenntnisse in Wort und Schrift Min. B2
- Kunden
- und lösungsorientiert, qualitätsbewusst und kommunikativ
- Erfahren in risikobasierter Entscheidungsfindung

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