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Quality Manager Medical Devices
vor 4 Wochen
Wyss Zurich_
**Quality Manager Medical Devices**
**80-100 % **:Das Wyss Zurich Translational Center (Wyss Zurich) ist ein gemeinsamer Accelerator der ETH Zürich und Universität Zürich, initiiert durch eine grosszügige Schenkung des Schweizer Unternehmers und Mäzens Dr. h.c. mult. Hansjörg Wyss. Die Mission von Wyss Zürich ist es, herausragende wissenschaftliche Entdeckungen in neue Therapien und bahnbrechende Innovationen in den aufstrebenden Bereichen Regenerative Medizin und Robotik voranzutreiben und Hybridtechnologien in diesen Bereichen zu fördern. Das Wyss Zurich bringt einige der weltweit führenden Expertinnen und Experten in multidisziplinären Teams zusammen und bündelt so ihr Wissen und ihre Expertise.
Wir suchen eine motivierte Persönlichkeit, die sich engagiert und verantwortungsvoll in die Betreuung und Verbesserung des QMS nach ISO 13485 einbringt und die Projektteams bei der Entwicklung von Medizinprodukten im Rahmen unserer QMS Prozesse unterstützt.
**Ihre Aufgaben**:
- Betreuung, Anwendung und kontinuierliche Verbesserung des Qualitätsmanagementsystems nach ISO 13485 für die Entwicklung von Medizinprodukten
- Schulung und Unterstützung der Projektteams bei der Anwendung der QM-Prozesse
- Unterstützung der Projektteams bei der Entwicklung des Medizinprodukts gemäss internen und externen Vorgaben (Gesetze, Normen)
- First-level support für Anwender des elektronischen Qualitätsmanagementsystems
- Durchführung von internen Audits
- Dokumentenmanagement, Abweichungsmanagement und Schulungsmanagement
- Mitarbeit bei QM-internen Projekten
**Ihr Profil**:
- Bachelor-Abschluss (oder höher) in LifeSciences oder technischer Fachrichtung bzw. verwandtem Fachgebiet (FH/ Universität oder äquivalente Ausbildung)
- >3 Jahre Arbeitserfahrung in relevanten Bereichen wie Qualitätsmanagement, Regulatory Affairs oder Produktentwicklung von Medizinprodukten
- Gute Kenntnisse der Medizinproduktentwicklung und der regulatorischen Vorgaben (MDR 745/2017, gesetzliche Grundlagen (HMG, MepV), ISO 13485, ISO 14971, IEC 62366 etc.)
Erfahrungen in den folgenden Bereichen sind ein Plus:
- Risikomanagement nach ISO 14971 für implantierbare bzw. Hochrisiko-Produkte
- Entwicklung von aktiven Medizinprodukten oder Software als Medizinprodukt (IEC 60601-1, IEC 62304)
- Usability Engineering (IEC 62366)
- Klinische Bewertung und klinische Studien (ISO 14155)
- Validierung und Anwendung von elektronischen Dokumentenmanagement-Systemen
- FDA-Zulassungen (21 CFR 820)
- Engagierte, proaktive Persönlichkeit mit Organisationstalent und genauer Arbeitsweise
- Sie sind flexibel, belastbar und arbeiten gerne im Team
- Die Schnittstelle aus reguliertem Arbeiten und innovativem Hochschulumfeld reizt Sie
- Sehr gute Deutschkenntnisse
- Sehr gute Englischkenntnisse
- Gute Computerkenntnisse (Office-Paket)
- Arbeiten im regulierten Umfeld (ISO 13485)
**Wir bieten Ihnen**: Sie erhalten die Möglichkeit, im internationalen Hochschulumfeld zu arbeiten und sich weiterzuentwickeln. Ein motiviertes und engagiertes Team unterstützt Sie dabei in allen Belangen.
Wenn Sie in einem spitzenmedizinischen Umfeld mitarbeiten wollen, dann freuen wir uns auf Ihre Bewerbung.
**Arbeitsort**: Moussonstrasse, Zürich, Schweiz
**Stellenantritt**: Der Stellenantritt erfolgt ab sofort oder nach Vereinbarung. Bitte reichen Sie Ihre Bewerbung bis am 15.02.2023 ein.
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