Björn Spies

Björn Spies Email and Phone Number

In the middle of difficulty lies opportunity @ inmedis GmbH
zug, switzerland
Björn Spies's Location
Stäfa, Zurich, Switzerland, Switzerland
About Björn Spies

Langjährige Erfahrung in der Medizintechnik. Entwicklung, Zulassung und Markteinführung, Marktüberwachung. Projektleitung, Qualitätsmanagement, Technische Dokumentation, PMS.

Björn Spies's Current Company Details
inmedis GmbH

Inmedis Gmbh

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In the middle of difficulty lies opportunity
zug, switzerland
Website:
inmedis.ch
Employees:
10
Björn Spies Work Experience Details
  • Inmedis Gmbh
    Senior Consultant
    Inmedis Gmbh Apr 2017 - Present
    Zug
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  • Medical Device Knowledge Units (Mdku) E.V.
    Expert Group Member
    Medical Device Knowledge Units (Mdku) E.V. Apr 2022 - Present
    Expert Group member for Technical Documentation
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  • Baumann Group
    Interim Project Manager
    Baumann Group Jun 2016 - Jun 2017
    Assignment as external Project Manager for Medical Device and Pharma customers.
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  • Depuy Synthes Companies Of Johnson&Johnson
    Complaint Handling Manager
    Depuy Synthes Companies Of Johnson&Johnson Dec 2013 - Mar 2016
    Basel Area, Switzerland
    Assignment as external consultant. Responsible for development andimplementation of global complaint processes for Power Tools.Definition of interfaces within the existing QMS (CAPA, NCR a.o.).Team lead for product complaint investigations in collaboration with productdevelopment, manufacturing and service
  • Qiagen Instruments Ag
    Platform Manager
    Qiagen Instruments Ag Feb 2009 - Feb 2013
    Hombrechtikon, Switzerland
    Overall responsibility for quality, availability and costs of automated platformsfor laboratory use in regulated markets during the lifecycle.Management of an interdisciplinary team (R&D, production, quality, supplychain) in collaboration with international system suppliers (USA, Malaysia).Responsibility for budget planning and control of product KPIs.International product certification of IVD products (CE-IVD, FDA PMA).Production transfers, product improvements, cost optimizations.
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  • Brainlab
    Project Engineer
    Brainlab May 2005 - Jan 2008
    Feldkirchen
    Responsible for the development and system integration of navigation software for image-guided surgery (orthopedics). Concept, specification, implementation, verification and validation. Technical documentation for interntional certifications.
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  • Denso Itlab
    Trainee Engineer
    Denso Itlab Oct 2003 - Mar 2004
    Tokyo, Japan
    Development and analysis of compensation methods for an illuminationinvariant face detection system.

Björn Spies Education Details

  • Universität Karlsruhe (Th)
    Universität Karlsruhe (Th)
    Diplom-Ingenieur Elektrotechnik
  • Tüv Süd
    Tüv Süd
    Manager Regulatory Affairs Medical Devices
  • Cqi / Irca Training 13485:2016 / Mdsap
    Cqi / Irca Training 13485:2016 / Mdsap
    Incorporating Iso 13485:2016 And Mdsap Requirements
  • Association For The Advancement Of Medical Instrumentation (Aami)
    Association For The Advancement Of Medical Instrumentation (Aami)
    Weiterbildung In Quality System Regulations Gemäss 21 Cfr Part 820
  • Bsi Academy Trainings For Quality Management And Auditing
    Bsi Academy Trainings For Quality Management And Auditing
    Lead Auditor En Iso 13485:2012

Frequently Asked Questions about Björn Spies

What company does Björn Spies work for?

Björn Spies works for Inmedis Gmbh

What is Björn Spies's role at the current company?

Björn Spies's current role is In the middle of difficulty lies opportunity.

What schools did Björn Spies attend?

Björn Spies attended Universität Karlsruhe (Th), Tüv Süd, Cqi / Irca Training 13485:2016 / Mdsap, Association For The Advancement Of Medical Instrumentation (Aami), Bsi Academy Trainings For Quality Management And Auditing.

Who are Björn Spies's colleagues?

Björn Spies's colleagues are Karim Badr, Daniel Fehr, Eveline Krummenacher, Claudio Bearth.

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