Jürgen Dr. Rettenmaier

certified and experienced Auditor GMP, ISO 17025,13485, 9001, 16949, 21CFR820, QSR, FDA

Weisslingen, Zurich, Switzerland

About

Profile: • 10 years experience in class III implantable medical devices • 8 years experience in the automotive industry • 8 years experience in the laser industry and mechanical engineering • more than 10 years experience in people management • Lead Auditor for ISO 13485, ISO 19001 ISO 13485, ISO 17025, 21 CFR 820, MDSAP GMP • Lead Auditor for the automotive & machining industry acc. to IATF 16949, ISO 9001, ... • Lead Auditor in MedTech acc. to ISO 13485, ISO 17025, 21 CFR 820, MDSAP GMP • 6-Sigma Green Belt • certified Validation Manager pharmaceuticals acc. to ICH Q7, Q9 and Q10

Experience

  • Risk Management & Post Market Surveillance at Zimmer Switzerland Manufacturing GmbH
    Sep 2022 - Present · 3 yrs 10 mos

    - Product Holds - CAPA - internal Audits

  • Supplier Quality Senior Engineer at Zimmer Biomet
    Sep 2014 - Aug 2022 · 8 yrs

    - certified Lead Auditor acc. to ISO 9001, ISO 13485, ISO 17025, 21 CFR 820, GMP in the EMEA Region - certified ICH Q7 Validation Manager - Qualification and Development of Suppliers in the EMEA Region - Strong Demand on Supplier Corrective Action Requests (SCAR) - Project Manager of Corrective and Preventive Actions (CAPA)

  • Senior Manager Quality Management Methods at Robert Bosch Battery Systems GmbH
    Oct 2011 - Aug 2014 · 2 yrs 11 mos

    - Manager for 8 Employees and 3 Consultants - Budget Responsibility for 2.5 Mio. € - Quality Management acc. to ISO/TS 16949, ISO 26262, CMMI - Representative of Occupational Health and Environmental Protection (HSE) - Implementation, Optimization und Evaluation of Standardized Quality Tools in Product Development: Q Gates, FMEA, DRBFM, APQP, PPAP, 8D, Audits

  • Corporate Supplier Manager at TRUMPF GmbH + Co. KG
    Aug 2008 - Sep 2011 · 3 yrs 2 mos

    - Team Leader of 2 Employees - Scheduling and Processing of Supplier Audits Globally, in Cooperation with the Corporate Purchasing Organizations - Establishing and Training of Standards on Auditing within the TRUMPF Group - Organization and Implementation of Training Courses Worldwide

  • Quality Manager (QMR) at TRUMPF Laser- und Systemtechnik GmbH
    Apr 2003 - Sep 2008 · 5 yrs 6 mos

    - Functional Leader for 7 Employees in the Quality Assurance of CO2-Laser and Special Machines - Representative of the Quality Management for the Laser/Electronics Division - Change Management of Core Processes with Viflow Process Landscapes - Accompanying of Customer and Certification Audits acc. to ISO 9001 and VDA 6 - Leader of 6 Six-Sigma Projects for the Optimization of Quality and Cost Cutting - Analysis of the Value Stream for the Continuous Improvement of TRUMPF Lean Production System - Processing of Internal and External Lean Production and Process Audits