Benjamin Straub
Bis 2022, Senior Quality Project Manager - Medical Device Development and QMS, Artidis AG
Bale, Schweiz
Über mich
With more than 21 years experience in the Medical Device / Combination Product Industry in Switzerland (English, German and French read and spoken), I can help you to develop your device and/or your Quality System. My 11 years experience as Project Manager and my 10 years experience as Senior Quality Manager helped me to understand the needs from the Industry and from the Health Authorities of the main market countries in the world, with regards to development of Devices for the Medical or Pharma industry. I propose you my expertise as Senior Quality Manager, in order to develop and/or to improve your device and/or Quality System, from early phase until market release.
Werdegang
Berufserfahrung von Benjamin Straub
Bis heute 2 Jahre und 2 Monate, seit Mai 2022
Looking for new challenges ! ;o)
At Home
1 Jahr, Mai 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 Jahre und 7 Monate, Okt. 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 Jahre und 7 Monate, Apr. 2012 - Okt. 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 Jahre und 3 Monate, Jan. 2008 - März 2012
Project Leader and Senior Product Development Engineer
Institut Straumann AGWithin 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 Jahre und 7 Monate, Juli 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 Jahr und 3 Monate, Jan. 1999 - März 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 Monate, März 1998 - Okt. 1998
Ingénieur Industrialisation
Bürkert et Cie
Recréer un lien entre le Bureau d'études et la Production
10 Monate, Dez. 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 Jahre und 1 Monat, Sep. 1992 - Sep. 1996
Mechanical Engineering MSc
INSA Strasbourg (formerly ENSAIS)
Génie Mécanique Ingénierie de Production
2 Jahre und 1 Monat, Sep. 1990 - Sep. 1992
Conception de produits Industriels
High school Jean Mermoz 68300 Saint-Louis
conception mécanique, dessin industriel
Sprachen
Französisch
Muttersprache
Deutsch
Fließend
Englisch
Fließend