Engineer TH-QK4E

Quality & regulatory engineer · Lead / Expert (10+ years)

Expert Quality- and Regulatory Affairs Medical Devices

Skills and tools

  • FDA 21 CFR Part 11
  • ISO 13485
  • ISO 14971
  • MDR 2017/745
  • IVDR 2017/746
  • GMP/GDP/GxP
  • Med.-Devices Class I-III
  • Auditor
  • MDSAP/FDA/MDR Audit-Scheme
  • CAPA
  • SQE/SQM
  • PRRC

Languages

DE native/native · EN C2/C2 · CH-DE speaks/understands · IT A1/A1

Work experience

  1. 2011 – 2026

    Project Consultant Medical Device und Pharma

    nationale und internationale Pharma- und Medizintechnikunternehmen und KMUs von 20 bis 10'000+ Mitarbeiter

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Tasks, schools and dates after login

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  1. 2007 – 2011

    Director Quality Management

    Start-Up im Bereich Dünnschicht-Solarmodule (500+ Mitarbeiter)

  2. 2004 – 2007

    Head of Process and Quality Management

    Internationaler Zulieferer der Halbleiter, Luftfahrt und Medizintechnikindustrie für Präzisisionsoptiken und

Education & further training

  1. Diplom-Ingenieur (FH) Physikalische Technik

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