Senior Quality Manager CAPA (m/w/d)
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Über Heraeus Medical
Wieder mobil werden bei schwerer Arthrose oder Knochenerkrankungen? Operationsergebnisse mit Knochenzement verbessern? Heraeus Medical bietet fortschrittliche Lösungen von der Orthopädie bis zum Infektionsmanagement. Exzellente Qualität treibt uns an und bringt Freude zurück – ins Leben von Patienten und in Ihren Job.
Was haben Sie vor? Spielen Sie bei Heraeus Medical in der Top-Liga der Medizintechnik!
Heraeus Medical mit Sitz in Wehrheim (Deutschland) ist eine Operating Company der Heraeus Gruppe. Diese liefert in den Bereichen Metals & Recycling, Healthcare, Semiconductor & Electronics und Industrials Qualität auf Weltklasseniveau. Als eines der Top-10-Familienunternehmen in Deutschland beschäftigt Heraeus rund 15.200 Mitarbeitende in 40 Ländern.
Das können Sie bewegen:
- In einem GMP‑regulierten Umfeld sichern Sie die Einhaltung aller Qualitäts‑, GMP‑ und regulatorischen Anforderungen entlang Herstellung, Prüfung und Versand.
- Abweichungen und CAPA steuern Sie von der Ursachenanalyse über die SAP‑basierte Umsetzung bis zum Wirksamkeitsnachweis und die Abschlussbewertung – gemeinsam mit den Prozessverantwortlichen.
- Die QM‑Landschaft entwickeln Sie weiter, indem Sie übergeordnete Anweisungen und Prozesse erstellen, pflegen und unternehmensweit schulen.
- Durch interne Trainings zu qualitätsrelevanten Themen erhöhen Sie Awareness und Compliance in den Teams.
- Herstelldokumentation prüfen Sie auf GMP‑Konformität, leiten Korrekturmaßnahmen ab und verfolgen deren Umsetzung nach.
- Als Sparringspartner der Fachabteilungen unterstützen Sie die Gestaltung GMP‑konformer Anweisungen und fördern stabile Prozessabläufe.
- QA‑Projekte treiben Sie voran und übernehmen bei Bedarf die Projektleitung; in Inspektionen vertreten Sie betreute Qualitätsprozesse souverän.
- Produkteinfluss und Patientensicherheit behalten Sie im Blick, indem Sie Ursachenforschung betreiben und fundierte Risikobewertungen erstellen.
Das bringen Sie mit:
- Abgeschlossenes naturwissenschaftliches Bachelor‑Studium, idealerweise mit Schwerpunkt Qualitätsmanagement
- Ausbildung zum Qualitätsbeauftragten oder entsprechende Berufserfahrung wünschenswert
- Mindestens 5 Jahre Berufserfahrung im Qualitätsmanagement im Medizinprodukte‑ oder Pharmaumfeld bzw. im Projektmanagement dieser Branchen
- Fundierte Kenntnisse relevanter regulatorischer Anforderungen: GMP, GDP, ISO 13485, FDA Quality System Regulation, MDR
- Gute Englischkenntnisse in Wort und Schrift
- Deutsch fließend in Wort und Schrift
Worauf Sie sich bei Heraeus Medical freuen können:
- Spannende Aufgaben – setzen Sie diese mit hoher Eigenverantwortung in einem ambitionierten Umfeld mit sehr guten Weiterentwicklungsmöglichkeiten um
- Attraktive Vergütung - starkes Grundgehalt nach Chemie-Tarifvertrag, jährliche Einmalzahlungen (Urlaubsgeld, 13. Tarifgehalt, Zukunftsbetrag) sowie Erweiterung der gesetzlichen Pflegeversicherung um eine Pflegezusatzversicherung
- Finanzielle Zusatzleistungen - Förderung der privaten Altersvorsorge, Lebensphasenkonto für bezahlte Freistellungen (z.B. Sabbatical, früherer Eintritt in den Ruhestand), Rabatte in vielen (Online-)Shops, Fahrradleasing
- Geregelte Arbeitszeiten - 37,5 Wochenstunden, wöchentlich 1-2 Tage mobiles Arbeiten, Freizeitausgleich für Überstunden, Altersfreizeiten, 30 Tage Jahresurlaub, Sonderurlaub für besondere Anlässe
- Gesundheit & Wohlbefinden - betriebsärztlicher Dienst mit umfassenden Vorsorgeuntersuchungen, Sozialberatung und hauseigene Mitarbeiterkantine mit täglich frisch zubereiteten Speisen
- Nachhaltigkeit und soziales Engagement - Nachhaltigkeit als Teil der Unternehmensstrategie und gezielte Förderung von Initiativen aus den Bereichen Bildung, Familie und Wissenschaft durch eigene Stiftungen
ReqID: 58825
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