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Skills
Leadership experience
On the Job Since 2014 Head of Supplier Management EMEIA Since 2012 Head of Steering Committee world wide IT configuration Since 2003 Executive Manager Production & Finance (member of executive management) 2000 - 2003 Manager Purchasing & Production (member of executive management) 1999 - 2000 Manager Production 1996 - 1998 Team Leader Technics 1993 - 1996 Deputy of Team Leader Technics
Project management experience (main projects with full responsibility)
2016-today
Business Analysis. FDA Consultant (Remediation Project). Coach for R&D Department. Proxy of Director R&D, CSV,
MDR transition, Reliability Analysis 2015-today
Business Analysis. Implementation of configuration strategy, establish configuration and implement Product Lifecycle Management Tool. Computer System Validation. 2015-today
Consult Various Investment Companies for investments in Medical Device industry 2015-2016
Implementation of Document Management System. Computer System Validation. 2014 - 2015
Establish new worldwide supplier management process including commodity strategy, low cost country strategy, inventory optimization and improved business processes. Everything related to full compliancy according to ISO and FDA QSR regulations. 2012 - 2015
Transfer of a complete product line (production, procurement, order processing, logistics) from US to Switzerland 2012 - 2014
Conversion of all devices produced in Switzerland to meet European RoHS directive and the US Conflict Minerals directive 2011 - 2012
Establishing a global matrix organization for manufacturing engineering. 2010 - 2012
Insourcing of complete production for electromechanical products 2009
Analysis and evaluation of potential manufacturers as well as subsequent implementation of a supply chain in Malaysia and China 2006 – 2008
SAP world wide harmonization and synchronization as well as an upgrade to ECC6.0 2007
Re-organization of operational organization 2004 - today
Enhancements with SAP (e.g. implementation of Document Management System, Controlling, Asset Management etc.) 2000 - today
Evaluation and integration of various 3rd party outsourcing partners 2004
Implementation of SAP R3 as ERP System 2000
Change of logistics set up from internal solution to an external one 1999
Re-organization of the teams „production“ and „purchasing & planning“ 1993 -1999
Various development projects for new tools and equipment including building the devices and training oft he users.
IT and Software Skills
SAP R3 4.6C / ECC6.0
MM, PP, SD, FI/CO, IM Modules (Excellent skills as user and configurator) SAP Netwaver
Excellent skills as user MS Excel
Excellent skills as user and developer (VBA, VB.net) MS Word
Excellent skills as user and developer (VBA, VB.net) MS Access
Excellent skills as user and developer (VBA, VB.net) Windows 2000, NT, XP,7
good skills as user Windows 95
good skills as user MS DOS 5.0 und 6.0
good skills as user Delphi / Visual Basic /VB.net
good skills as user and developer (VBA, VB.net) SPS (PLC)
good skills as developer (Simatic 5 and 7)
Quality Assurance and Regulatory Affairs skills
ISO
ISO 14971
ISO 9000
ISO 13485
FDA
21 CFR Part 820
21 CFR Part 11
Others
Medical Device Directive 93/42/EEC
MDR
RoHS Drective
REACH Directive
GMP, GDP
Projekthistorie
01/2022
-
bis jetzt
Projectmanager MDR
(Pharma und Medizintechnik, 500-1000 Mitarbeiter)
up-lift from MDD to MDR
07/2016
-
bis jetzt
Project Manager Remediation
(Pharma und Medizintechnik, >10.000 Mitarbeiter)
02/2015
-
bis jetzt
Configuration Manager
(Pharma und Medizintechnik, >10.000 Mitarbeiter)
03/2015
-
07/2016
Implementation Lead DMS and PLC
(Pharma und Medizintechnik, >10.000 Mitarbeiter)
Reisebereitschaft
Verfügbar in den Ländern
Deutschland, Österreich und Schweiz
Global
Sonstige Angaben
Keine Rechtsunsicherheit in Deutschland wegen Freelancer Status - Wir sind eine GmbH!
Wir haben nebst MM, PP, SD und anderen Supply Chain bezogenen Experten auch einen sehr erfahrenen Senior Project Manager für FI / CO
Wir bieten auch Beratungen, Schulungen, Dokumentationen und auf Wunsch auch Validierungen an - speziell für Medical Device Manufacturers gemäss ISO 13485, FDA 21CFR820 und 21CFR Part11, MDR, MDD und GxP
ABA International Consulting GmbH
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