Director of Quality Assurance

vor 2 Wochen

Bern, Schweiz ROCKEN Vollzeit

**Deine Verantwortung**:

- Sie leiten und führen personell den Bereich QM / RA mit drei Mitarbeitenden.
- Sie sind verantwortlich für die Leitung des Qualitätsmanagementsystems nach EN ISO 13485, MDR, FDA 820 und GMP.
- Im Rahmen der PRRC sind Sie zuständig für die Prüfung der Konformität der Medizinprodukte, die technische Dokumentation (auch deren Aktualität), Marktüberwachung und das Meldewesen.
- Sie stellen sicher, dass das Qualitätsmanagementsystem gemäß EN ISO 13485, MDR, FDA 820 und GMP, alle Medtech Prozesse gemäß den geltenden Anforderungen, die Wirksamkeit und Aufrechterhaltung des QMS sowie die Durchführung von Behörden
- und Zertifizierungsaudits gewährleistet sind.
- Sie setzen die operativen Ziele um unter Berücksichtigung der Termin-, Qualitäts
- und Kostenziele.

**Deine Skills**:

- Mindestens 5 Jahre Berufs
- und Führungserfahrung im Bereich Qualitätsmanagement der Medizintechnikbranche oder in einer ähnlichen Funktion
- Mehrere Jahre Berufserfahrung im Bereich Regulatory Affairs in der Medizintechnik branche von Vorteil
- Gute Kenntnisse der ISO 13485:2016 und der EU MDR 2017 / 745
- Erfahrungen im Projekt
- und Prozessmanagement und Auditieren
- Analytische und konzeptionelle Denkweise, selbständige und proaktive Arbeitsweise
- Sie kommunizieren fliessend in Deutsch und Englisch (schriftlich/mündlich)

**Benefits**:

- ** Gute Verkehrsanbindung und Erreichbarkeit**:

- ** Komfortables Büro mit moderner Infrastruktur**:

- ** Interessante und abwechslungsreiche Tätigkeiten/Projekte**:

- ** Eingespieltes und dynamisches Team**:

- **Flache Hierarchien**:

- ** Internationales Umfeld**:

- ** 13. Monatsgehalt**

**ROCKEN Jobs**:
**Profil erstellen**:
2 - 5 years

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