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Product Quality Lifecycle Manager
vor 4 Monaten
Wer wir sind:
JENPERSONAL fokussiert sich auf Branchen, in denen Erfahrung, Marktkenntnisse und Fachwissen wesentliche Kriterien für die Besetzung von Schlüsselpositionen im Hochtechnologiesektor sind. Wir sind spezialisierte Personalberater für Unternehmen im Technologiesektor, die effektiv bei der Suche und Auswahl von Spezialisten und Führungskräften unterstützen.
Product Quality Lifecycle Manager (m/w/x)
Einsatzort: Aalen (Württemberg)
Art(en) der Anstellung: Vollzeit
Arbeitszeit: Stunden pro Woche
Verantwortungsbereich:
- Hauptaufgabe: Technische Dokumentation für Medizinprodukte.
- Gewährleistung der Vollständigkeit und Konformität der Produktakte gemäß den Produktanforderungen für die internationale Zulassung.
- Bewertung von Standards und deren Umsetzung in Design Input und Testkonzepte.
- Bewertung von Prüfberichten zur Verifizierung und Validierung des Design Output.
- Risikomanagement durch Leitung von FMEA-Workshops, Unterstützung des Risikomanagements von Produkten und kontinuierliche Weiterentwicklung des Risk Management Prozesses.
- Verantwortung für das Reklamations- und Nichtkonformitätsmanagement mit Ursachenanalyse und prozesskonformer Dokumentation.
- Unterstützung bei internen und 3rd-Party-Audit-Aktivitäten sowie Einführung und Umsetzung digitaler Plattformen für Design- und QMS-Prozesse.
Anforderungsprofil:
- Abgeschlossenes Bachelor- oder Masterstudium im Bereich Technik oder Naturwissenschaften.
- Berufserfahrung im Qualitätsmanagement, idealerweise in der Medizintechnik.
- Erfahrung im Projektmanagement und fachlicher Überprüfung von Arbeitsergebnissen.
- Kenntnisse zu ISO 13485, MDR, MDSAP, ISO 14971 und weiteren Marktanforderungen (FDA, NMPA, TGA) von Vorteil.
- Sorgfältige, termingerechte und selbstständige Arbeitsweise.
- Verhandlungssicher in Englisch in Wort und Schrift.
Was Sie erwartet:
- Vielfältige Herausforderungen in einem Hochtechnologieunternehmen.
- Unbefristeter Arbeitsvertrag mit Übernahmemöglichkeit bei guter Leistung.
- Übertariflicher Lohn und Möglichkeit zur Flexibilisierung von Überstunden.
- Persönliche Betreuung und Unterstützung durch Kollegen.
- Umfangreiche Einarbeitung durch den Kunden vor Ort.
- Teamorientierte Unternehmenskultur und offene Kommunikation.
- Vertraulicher Umgang mit persönlichen Daten gemäß den Datenschutzrichtlinien.
Art(en) des Personalbedarfs: Neubesetzung
