Harald Marzell

Angestellt, Vice President Quality Assurance, Commercial Operations, Region Europe, Fresenius Kabi AG
Bad Homburg, Germany

Fähigkeiten und Kenntnisse

Managing QA Teams worldwide
Implementing & Managing QMS ISO 9001 / 13485
QM System and Process Auditor
GMP Compliance
GDP Expert
Implementation MDR 2017/745
Medical Device QA System MDD 93/42
FMEA
GMP
CAPA
International Registration of Medical Devices
Long experinece in International RA Requirements
Strong organisational skills and target-oriented
Führungserfahrung
Eigenverantwortung
Loyalität
Kontaktfreudigkeit

Werdegang

Berufserfahrung von Harald Marzell

  • Current 2 years and 11 months, since Jul 2023

    Vice President Quality Assurance, Commercial Operations, Region Europe

    Fresenius Kabi AG

  • Current 6 years and 4 months, since Feb 2020

    VP Quality Assurance, Commercial Business Center, Commercial Organisation

    Fresenius Kabi AG

  • 4 years and 6 months, Sep 2015 - Feb 2020

    Director Quality Assurance-Region ELAMA-Europe, Latin America, MiddleEast&Africa

    Fresenius Kabi AG

  • 2 years and 8 months, Jan 2013 - Aug 2015

    Head of QM / QA Active Blood Devices

    Fresenius HemoCare GmbH

  • 1 year and 8 months, May 2011 - Dec 2012

    Corporate Regulatory Affairs Manager Medical Devices

    Fresenius Kabi AG

    Coordination International Registration Medical Device portfolio of Fresenius Kabi, RA Consultant for I&DC's, Production Units and Market Units

  • 1 year and 1 month, Apr 2010 - Apr 2011

    Senior Manager Quality Management

    Fresenius Kabi D-GmbH

    Quality Management System Fresenius Kabi QM-Auditor (DIN EN ISO 13485, MDD, GMP), Lead CAPA-Manager

  • 1 year and 4 months, Dec 2008 - Mar 2010

    Senior Manager Production Operations

    Fresenius Kabi D-GmbH

    Department responsible: Complaint handling, QC Lab, Product modification, Labelling team, Supplier support and relation, QA - CE Product File,

  • 1 year and 10 months, Feb 2007 - Nov 2008

    GMP Compliance Consultant

    NNE Pharmaplan GmbH

    Division Quality & Validation Assurance

  • 3 years and 1 month, Jan 2004 - Jan 2007

    Quality Assurance Manager

    Fresenius Kabi D-GmbH

    Quality Assurance Manager Division Application Devices (enteral and parenteral nutrition, iV, urology, compounding)

  • 6 years and 2 months, Nov 1997 - Dec 2003

    Project Engineer Research and Development

    Fresenius AG / Transfusion Technology GmbH

    Development of active and non-active Medical Devices

Ausbildung von Harald Marzell

  • 5 years and 7 months, Sep 1992 - Mar 1998

    Technisches Gesundheitswesen

    Fachhochschule Giessen-Friedberg

    Biomedizintechnik / Biomedical Engineering

Sprachen

  • German

    C2 (Verhandlungssicher / Muttersprachlich)

  • English

    C1 (Fließend)

  • Romanian

    C1 (Fließend)

  • Italian

    A1-A2 (Grundkenntnisse)

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