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Celestin Leupi

Celestin Leupi

Research Engineer /QA Support

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location of Celestin LeupiForel, Vaud, Switzerland

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  • Timeline

  • About me

    Expert & Senior Manager | Quality Assurance & Regulatory Compliance | Operational Excellence & Continuous Improvement | LifeSciences (Medtech & Healthcare)

  • Education

    • Ecole Polytechnique Federale de Lausanne

      2001 - 2005
      PhD Thesis Mechanical Engineering

      Activities and Societies: - Ingénieur du Monde - Alumni

    • School of Engineering - ENSET, Douala Cameroon

      1996 - 1998
      Mechanical Engineering Diploma Mechanical Engineering

      Activities and Societies: Football

    • Emergo

      2019 - 2019
      Certificate of completion MDR 2017/745 Medical Devices regulation- MDR 2017/745

    • EPFL- CREATE

      2002 - 2003
      Entrepreneurship and Innovation certificate Business Development

      Activities and Societies: CREATE-EPFL Entrepreneurship Ingénieur du Monde

    • Ecole polytechnique fédérale de Lausanne

      2010 -
      Attestation in Collaborative Management Management Collaboratif - KIJ Method

      Activities and Societies: Rezonnance-EPFL Gestion de groupe et animation de synergie et brainstorming en vue d'élaborer un canevas dans le but d'atteindre un objectif commun.

    • HEIG-VD

      2013 -
      OPAM (Ordonnance pour la Protection contre les Risques d'Accidents Majeurs) Management des Risques

      Activities and Societies: HEIG-VD Formation en mesures pratiques et réglementaires de protection et de prévention des accidents majeurs en industrie

    • Ecole polytechnique fédérale de Lausanne

      1999 - 2001
      Master EPFL and Postgrade Mechanical and Hydraulics + Computational Engineering

      Activities and Societies: Alumni A3EPFL Ingénieur du Monde

    • Ecole polytechnique fédérale de Lausanne

      2002 - 2003
      Entrepreneurship & innovation Business Development & technology Development

      Activities and Societies: CREATE-EPFL; Swiss Venture Formation en création et gestion d'entreprise et développement de business model.

  • Experience

    • Ecole Polytechnique Federale de Lausanne - EPFL

      Oct 1999 - Oct 2005
      Research Engineer /QA Support

    • MTD GROUP

      Feb 2006 - Sept 2013
      QA Leader

    • Centre Hospitalier Universitaire -CHUV

      Feb 2014 - May 2017
      Medical Device Program Manager at CHUV

    • Biosense Webster AG/Johnson & Johnson AG, Switzerland

      Mar 2014 - May 2017
      Consultant/Senior QA and Clinical Support Specialist

    • Produits Dentaires SA

      Jun 2017 - Dec 2017
      Senior QA Specialist/Quality Project Management

    • Vyaire Medical

      Sept 2018 - Feb 2021
      Head of QMS (Quality Management Systems)

    • EBAMed SA

      Nov 2021 - Nov 2022
      Senior QARA Manager/Risk Manager

    • Zepter International (official page) // Bioptron AG

      Dec 2022 - Oct 2023
      Quality Assurance & Regulatory Affairs (QARA) Leader/ EU-MDR-Project Leader

    • Synthes GmbH

      Dec 2023 - Mar 2024
      GMP Compliance Specialist

  • Licenses & Certifications

    • Application of Risk Management to Medical Devices, ISO 14971:2019

      BSI, Germany.
      May 2020

    • Project Management Professional (PMP)

      Project Management Institute-PMI
      Sept 2010

    • Good Clinical Practice - GCP

      Ecole polytechnique fédérale de Lausanne & CHUV
      Jan 2014

    • MDSAP Auditor under ISO 13495:2016 for QMS

      BSI Training Academy
      Oct 2019

    • ISO 13485:2016 Lead Auditor of Quality Management Systems

      IRCA and CQI
      Dec 2018