Technical File Assessor for Ivd Products

vor 1 Woche


Hamburg, Hamburg, Deutschland TÜV SÜD Product Service GmbH Vollzeit
Seit 1866 gilt unsere Leidenschaft der Technik und der Sicherheit. Innovationen beeinflussen unser Leben in vielfältiger Weise.

Für die Sicherheit von Menschen und der Gesellschaft setzen wir uns jeden Tag aufs Neue ein und schaffen Vertrauen in neue Technologien.

Wir sind Teil des Fortschritts. Wir beraten, wir prüfen, wir zertifizieren. Wir handeln aus Überzeugung, gestalten schon heute die Welt von morgen - setzen Zeichen. Wir nehmen die Zukunft in die Hand. Wir sind TÜV SÜD Mitarbeiter an weltweit 1.000 Standorten.

Aufgabe

  • Evaluation of technical documentation, product dossiers and test results of production batches of invitro diagnostic products, mostly class D products for blood grouping
  • Writing technical reports and interaction with international clients
  • Supporting the entire certification project through proactive problemsolving and effective management of internal interfaces
  • Collaboration in an international team for technical assessment of national and international clients

Qualifikation

  • Completed master&;s degree in a scientific field, e.g. biology, biochemistry or biotechnology (PhD is a plus)
  • At least four years of professional experience in the diagnostics industry with blood grouping products (e.g. AB0, Rhesus), particularly in design and development
  • Sound knowledge of immunology, molecular biology and related techniques
  • Enthusiasm, passion and good selfmanagement skills

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- #Sandra+Heinig

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