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Ralf Reitzig

Angestellt, Quality System Compliance Manager EMEA, DePuy Synthes Companies of Johnson & Johnson
Zuchwil, Schweiz

Fähigkeiten und Kenntnisse

Medical Devices
Quality Management
21 CFR 820
EN ISO 13485
EN ISO 9001
CAPA
Auditing
Audit Preparation
International Experience
93/42/EWG
Project Management
Qualiy Assurance
ISO/TS 16949

Werdegang

Berufserfahrung von Ralf Reitzig

  • Bis heute 12 Jahre und 9 Monate, seit Sep. 2012

    Quality System Compliance Manager EMEA

    DePuy Synthes Companies of Johnson & Johnson

    • Development, establishment and successful execution of internal audit program for 14 sites in Switzerland, Germany and China • Reduction of FDA, Notified Body and other Health authorities observations by more than 50% • Build up the Quality Systems Compliance Team from 0 to 9 employee • Successful development of high potential employees to further internal positions • Leading the team through acquisition and transformation activities to get integrated into Johnson & Johnson

  • 1 Jahr und 10 Monate, Nov. 2010 - Aug. 2012

    CAPA Engineer

    Stryker Osteosynthesis AG

    • Reduction of open CAPAs by > 80% by driving significant process changes, continuous education of CAPA owners and management • Establishment of appropriate report and escalation system • Representation of CAPA process within FDA and Notified Body inspections without observations

  • 2 Jahre und 1 Monat, Okt. 2008 - Okt. 2010

    Quality Manager

    Swissbit

    • Successfully representation of Swissbit Quality System during Notified Body audits and customer audits • Increase of FPY from 65% to > 99% for new introduced technologies by establishing statistical methods for production process development, FMEAs and reporting system • Driving increase of supplier quality through audits, on-site visits and cooperation with internal technology development department • Leading a team of 8 employees from task based to team approach

  • 1 Jahr und 5 Monate, Mai 2007 - Sep. 2008

    Quality Engineer Pacemakers / Defibrilators

    Biotronik

    • Development and implementation of software based solutions to identify and report trends in failure modes • Member of Change Control Review Board • Team member of a worldwide team to develop and implement Statistical Process Control methods

  • 4 Jahre und 2 Monate, März 2003 - Apr. 2007

    Development Engineer Production Tests

    AVM

    • Conceptual design and development of production test for the FRITZ!Box product family for industrial mass production • Realisation of test strategies at suppliers in Germany and China • Design, development and establishment of methods to measure suppliers performance

  • 1996 - 2003

    Production Testing

    Siemens

Ausbildung von Ralf Reitzig

  • FHTW Berlin

Sprachen

  • Deutsch

    -

  • Englisch

    -

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