Roland Herkströter

Angestellt, Sr Manager Statistical Techniques and Validations, Fresenius Medical Care

Frankfurt Rhein-Main Area, Deutschland

Fähigkeiten und Kenntnisse

Process Validation
Medical Devices
GMP
Process Excellence
Manufacturing
R&D
Life Science Industry
Process Optimization
Process Engineering
Six Sigma
DoE

Werdegang

Berufserfahrung von Roland Herkströter

  • Bis heute 8 Jahre und 1 Monat, seit Apr. 2016

    Sr Manager Statistical Techniques and Validations

    Fresenius Medical Care

    Corporate SME on applied statistics and validation approaches in manufacturing. Coaching manufacturing sites in establishing processes and achieving compliance with FDA 21CFR820 in the areas acceptance sampling (Incoming, In-Process and Final Acceptance), process validation and statistical trending of quality data.

  • 4 Jahre und 10 Monate, März 2014 - Dez. 2018

    Managing Director

    EVOP GmbH | Process Excellence for the Life Science Industry

    EVOP is a highly specialized consultant business serving FDA and ISO13485 regulated industries in Germany. On site Six Sigma and process optimization projects as well as FDA compliant validations are our core competencies. evop-gmbh.de

  • 3 Jahre und 1 Monat, März 2011 - März 2014

    Consultant / Staff Engineer New Process Development

    Johnson & Johnson, USA

    NPD, Lean and process optimization for pilot production ramp-up and transfer of diagnostic and therapeutic cardiac catheters.

  • 3 Jahre und 7 Monate, Feb. 2008 - Aug. 2011

    Manager Process Engineering

    CooperVison Inc., California

Ausbildung von Roland Herkströter

  • 2005 - 2008

    International Marketing Management

    Technische Hochschule Mittelhessen - THM Giessen/Friedberg

  • 1990 - 1997

    Physikalische Technik

    FH Wiesbaden-Ruesselsheim

Sprachen

  • Deutsch

    Muttersprache

  • Englisch

    Fließend

Interessen

Connect with people in the Life Sciences Industry
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