Benjamin Straub

est en pleine forme.🥦

Bis 2022, Senior Quality Project Manager - Medical Device Development and QMS, Artidis AG
Bale, Switzerland

Fähigkeiten und Kenntnisse

Master degree in Mechanics
French+German+English
Medical Technologies know-how
Know-how in Standardized and Documented projects
MedTech
Risk Management
Medical Devices
Medical Device Regulation (MDR)
Quality Management Systems
Quality Management
Project management
Good Documentation Practice
GMP Compliance
cGMP
ISO 13485
Decision Making
Complaint management
Risk evaluation
ISO 14971
Tolerance stack
Manage technical complaints
Combination Products
Drug products
Manufacturing Operations
Packaging
CMO management

Werdegang

Berufserfahrung von Benjamin Straub

  • Current 4 years and 1 month, since May 2022

    Looking for new challenges ! ;o)

    At Home

  • 1 year, May 2021 - Apr 2022

    Senior Quality Project Manager - Medical Device Development and QMS

    Artidis AG

    Creation, documentation and training of the team for the Quality Management System. Supervision of the Device Development Documentation (Technical File). Training of management and young people of a start-up regarding Medical Device requirements and subtilities.

  • 5 years and 7 months, Oct 2015 - Apr 2021

    Medical Device Quality – Senior Project Manager

    F.Hoffmann-La Roche AG

    Ensure GMP documentation in accordance with internal procedures and Health Authorities / international standards requirements and ensure sound technical content for internal Knowledge Management. Participation of creation, review and signature of all Design History File documents, like Risk Management, Project Planning, Design Inputs, Design Outputs, Design Verification, Design Validation, Process Development, Test Method Validation, Change Management, Discrepancies Management, etc.

  • 3 years and 7 months, Apr 2012 - Oct 2015

    External Quality – Senior CMO and Project Manager

    F. Hoffmann-La Roche Ltd

    Management of Quality aspects of CMOs like Quality Agreements, Deviations, Changes, Supply Specifications, Contracts, etc. Other task was the management of QA aspects for the Device Development project documentation, like Risk Management, Design Input Design Outputs, Design Verification, Design Validation, Process Development, Changes, Deviations, etc.

  • 4 years and 3 months, Jan 2008 - Mar 2012

    Project Leader and Senior Product Development Engineer

    Institut Straumann AG

    Within the CAD/CAM project, lead of project and technical development of helping parts in order to allow a scanner+software system to find the position of a dental implant in a cast model or in the oral cavity of a patient (scanbodies for Etkon System). Other activities : project lead for Plan Abutments and Life Cycle Management for BU Prosthetics.

  • 7 years and 7 months, Jul 2000 - Jan 2008

    Senior Product Development Engineer for medical Implants

    Synthes AG (formerly Stratec Medical)

    Senior Product Development Engineer for medical Implants in traumatology (2000-2004) and in CMF-Neuro/Thorax (2005-2008), Plates, Screws and general Instrumentation for bone fixation. Together with the Product Manager, development of implants and their associated instruments. Main project in Traumatology: LCP, system of implants, where the screws are locked in the plate with angular stability.

  • 1 year and 3 months, Jan 1999 - Mar 2000

    Chef de projet Adjoint

    Industrie Automation

    Chef de projet adjoint, en charge de la conception / réalisation / suivi de 21 machine d'assemblages automatiques pour moteur de voiture sur ligne d'assemblage

  • 8 months, Mar 1998 - Oct 1998

    Ingénieur Industrialisation

    Bürkert et Cie

    Recréer un lien entre le Bureau d'études et la Production

  • 10 months, Dec 1996 - Sep 1997

    Soldat

    Armée Française

    Secrétaire du Colonel au Budget de l'Armée Française au sein du Corps Européen de Strasbourg

Ausbildung von Benjamin Straub

  • 4 years and 1 month, Sep 1992 - Sep 1996

    Mechanical Engineering MSc

    INSA Strasbourg (formerly ENSAIS)

    Génie Mécanique Ingénierie de Production

  • 2 years and 1 month, Sep 1990 - Sep 1992

    Conception de produits Industriels

    High school Jean Mermoz 68300 Saint-Louis

    conception mécanique, dessin industriel

Sprachen

  • French

    C2 (Verhandlungssicher / Muttersprachlich)

  • German

    C1 (Fließend)

  • English

    C1 (Fließend)

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