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Bischoff Gerlinde

Wissenschaftlicher Mitarbeiter

207 followers

Greater Freiburg Area

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Timeline
About me
Expert in medical product development
Education
- Freie Universität Berlin
  1989 - 1995
  Dr. rer. nat. Chemie 2
- Technische Universität Berlin
  1982 - 1989
  Diplom Chemie 1.7
  Activities and Societies: DECHEMA
Experience
- Martin Luther University Halle-Wittenberg
  Sept 1996 - Aug 2004
  Wissenschaftlicher Mitarbeiter
- Covidien
  Jan 2005 - Apr 2015
  Development new productsQualification new products and product modificationsOperation excellenceProduct designDesign controlChange control according ISO 13485, CFR Part 820 QSR and Medical Device DirectiveLean management Train the trainerEngineering studies and reportingBiocompatibility (acc. ISO 10993) and preservation of medical products (acc. Ph.Eur.)GMPSafety laboratory (Germany)Entwicklung, Qualifizierung und Einführung neuer ProdukteProjektleitung zur Produktverbesserungen und KostenreduzierungLean ManagementAnleitung von Mitarbeitern in der Durchführung von Projekten, KaizensProduktänderungen gemäß ISO 13485, CFR Part 820 QSR und Medical Device DirectiveSicherheit im Labor (TRGS 526 und BGI/GUV-I 850-0) Show less
  - Sustaining Leader / Leitung Produktpflege
    Oct 2008 - Apr 2015
  - R&D Scientist
    Jan 2005 - Sept 2008
- VascoMed / Biotronik
  May 2015 - now
  Design Validation Medical Products Class III
  - Director Product Quality
    Apr 2018 - now
  - Director Design Validation / Gruppenleiter Design Validierung
    May 2015 - Mar 2018
Licenses & Certifications
- Dr. rer. nat.
  Freie Universität Berlin
Volunteer Experience
- Gutachter
  Issued by European Commission for standardization on Jun 1999
  Associated with Bischoff Gerlinde