Product Safety Manager

vor 4 Wochen

Forchheim, Bayern, Deutschland Siemens Healthineers AG Vollzeit

Gestalten Sie die Zukunft im Gesundheitswesen mit Siemens Healthineers

Wir bei Siemens Healthineers suchen engagierte Talente, die bereit sind, ihre Energie und Leidenschaft in die Weiterentwicklung der Gesundheitsbranche zu investieren. Unser Unternehmen steht für Innovation und eine lange Tradition als führender Technologiekonzern im dynamischen Gesundheitssektor.

Werden Sie Teil unseres globalen Teams als Produkt-Sicherheitsmanager (w/m/d) im Bereich Computertomographie (CT).

Flexible Arbeitsmodelle: In Abstimmung mit Ihrer Führungskraft haben Sie die Möglichkeit, bis zu 60% Ihrer Arbeitszeit mobil zu gestalten.

Vollzeit oder Teilzeit: Diese Position kann in Vollzeit oder Teilzeit mit mindestens 30 Stunden pro Woche besetzt werden.

Ihre Aufgaben und Verantwortlichkeiten:

  • Sie sind verantwortlich für das Produkt-Sicherheitsmanagement, einschließlich der Identifizierung, Bewertung und Minimierung von Risiken gemäß ISO 14971 bei der Entwicklung neuer Produkte.
  • Sie begleiten Entwicklungsprojekte und definieren zusammen mit technischen Experten Maßnahmen zur Risikominderung.
  • Sie überwachen kontinuierlich die Erkenntnisse aus der installierten Basis gemäß den Vorgaben der Marktüberwachung und aktualisieren die Risikobewertungen bei Bedarf.
  • Sie unterstützen bei der Produktzulassung, indem Sie relevante Informationen für die zuständigen Behörden bereitstellen.
  • In Ihrer Rolle als Sicherheitsmanager nehmen Sie an internen und externen Audits teil.
  • Zusammen mit Ihrem Team im Risikomanagement gestalten und optimieren Sie den Risikomanagementprozess und treiben kontinuierliche Verbesserungen voran.
  • Sie arbeiten eng mit der Niederlassung in Shanghai zusammen, um die oben genannten Verantwortlichkeiten zu erfüllen.

Qualifikationen und Erfahrung:

  • Abgeschlossenes Studium im Ingenieurwesen, Naturwissenschaften oder einem verwandten Bereich.
  • Langjährige Berufserfahrung und fundiertes technisches Verständnis komplexer medizinischer Produkte (Hardware und Software), idealerweise im Bereich der Computertomographie.
  • Erfahrung im Qualitätsmanagement von Medizinprodukten.
  • Kenntnisse der relevanten Gesetze und Vorschriften für Medizinprodukte (z.B. ISO 14971, ISO 13485/9001, FDA QSR, MDR/MDD) sind von Vorteil.

Ihr Profil und Ihre Fähigkeiten:

  • Verhandlungssichere Deutschkenntnisse und sehr gute Englischkenntnisse in Wort und Schrift, ergänzt durch interkulturelle Erfahrung.
  • Hohes Qualitätsbewusstsein, Eigeninitiative und die Fähigkeit, in interdisziplinären Teams zu arbeiten.
  • Teamplayer mit ausgeprägten Kommunikationsfähigkeiten, auch in herausfordernden Situationen.
  • Analytisches Denken, hohe Eigenverantwortung und Flexibilität sind Ihre Stärken.

Über Siemens Healthineers: Siemens Healthineers ist ein weltweit führendes Unternehmen im Bereich Medizintechnik. Mit über 50.000 engagierten Mitarbeitenden in mehr als 75 Ländern gestalten wir die Zukunft des Gesundheitswesens. Täglich profitieren Millionen von Patient*innen von unseren innovativen Technologien und Dienstleistungen in den Bereichen Diagnostik, therapeutische Bildgebung und digitale Gesundheitslösungen.

Unsere Unternehmenskultur: Wir schätzen Vielfalt, offene Diskussionen und den Mut, Konventionen in Frage zu stellen. Ständiger Wandel ist Teil unseres Arbeitsalltags, und wir laden Sie ein, neue Herausforderungen anzunehmen und Ihre Ideen zu verwirklichen.

Wir freuen uns auf Bewerbungen von Menschen mit unterschiedlichen Hintergründen und insbesondere von Personen mit Behinderungen.

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