Multiple Projects such as:
- MDR Uplift for Heart Lung Machines (Class IIb) and Heater Cooler Units
-Product Transfer from USA/Sweden to Germany
- Reliability calculations and tests
consult investment companies in medical devices, mainly radiation therapy
2016-heute (Medical Devices)
Business Analysis. FDA Consultant (Remediation Project). Coach for R&D Department. Proxy of Director R&D, CSV
2015- heute (HighTech Company)
Configuration Management, PLM, Software Anpassungen
Business Analysis. Implementation of configuration strategy, establish configuration and implement Product Lifecycle Management Tool. Computer System Validation.
2015 - heute (Investment Companies)
Beratung von Investment Firmen im Bereich Radioonkologie und Laserpositioniersysteme
2015- 2017 (Pharma / Medical Devices)
DHF Prozess Implementation, PLM Tool Evaluation & Configuration
2014 - 2015
Einführung eines NPI (New Product Introduction) Systems mit SAP Daten (CAD, BOM, MM, etc.)
2014 - heute
Erarbeiten und Einführen eines globalen Lieferantenmanagement-prozesses inclusive Commodity Strategie, Low Cost Country Strategie, Inventar Optimierung, sowie allgemeine Verbesserung der Prozesse. Alle Prozesse und Dokumente wurden ISO 13485 und FDA QSR 21CFR820 und Part11 konform erstellt.
2014
Transfer einer kompletten Produktlinie (inclusive Produktion, Outsourcing, Beschaffung, Auftragsabwicklung, Manufacturing Engineering und Logistik) aus der Schweiz in die USA
2012 - 2014
Transfer einer kompletten Produktlinie (inclusive Produktion, Outsourcing, Beschaffung, Auftragsabwicklung, Manufacturing Engineering und Logistik) aus den USA in die Schweiz und EU.
2012 - 2014
Umstellung und Anpassung aller in der Schweiz gefertigter Komponenten und Produkte, so dass sie konform der Europäischen RoHS Direktive und der US Conflict Minerals Direktive sind
2011 - 2012
Erarbeitung und Aufstellung einer globalen Matrixorganisation für Manufacturing Engineering.
2010 - 2012
Insourcing der kompletten Produktionssteuerung und ?Abwicklung für mechanische Produkte und Komponenten.
2009 - 2010
Erarbeiten und Einführen eines globale Retouren- und Reparaturenmanagementprozesses (RMA) und entwickeln der Prozesse für SAP
2009
Analyse der Marktsituationen für Beschaffung, Evaluation möglicher Hersteller sowie die Einführung einer Supply Chain in Malaysia und China
2008
Einführung von Asset Management in SAP (für Anlagevermögen)
2006 ? 2008
Weltweite SAP Harmonisierung und Synchronisation, sowie ein Upgrade auf SAP ECC6.0 inklusive Datenbereinigung, Tests, Dokumentation und Anwendertrainings.
2007
Re-organisation der operative Organisation (Beschaffung, Planung, Manufacturing Engineering, Auftragsabwicklung, Logistik, Computer Systeme, Projektmanagement und Finanz/Controlling).
2006
Einführung eines Controlling Systems für das operative Business mit SAP Daten.
2004 - 2005
Einführung eines Dokumenten Managementsystems in SAP
2000 - heute
Evaluierung und Integration mehrerer Outsourcing Partner weltweit
2004
Einführung von SAP R3 als ERP System
2000
Änderung der Logistik und der Lagerhaltung von interner zu externer Lösung
1999
Reorganisation der Teams ?Produktion? und ?Beschaffung und Planung
1993 -1999
Verschiedenste Entwicklungsprojekte für Geräte und Maschinen inklusive deren Bau, Test und Benutzerschulungen.
Experience in Logistics and Supply Chain Management
Reto Hauri
CEO & Chairman, Projectmanager
All listed projects have been elaborated and performed according to Quality System Regulations (QSR), 21CFR820, 21CFR11, ISO13485, GxP and GAMP regulations and methods..
Selection from Projects:
Project
Where
When
Management of Logistics and Procurement Groups
Global
1999-2015
Subcontracting (Outsourced Manufacturing) at 3rd Party Suppliers
Global
1999-2015
Improvinng and Optimizing of Supply Chain and Logistics Processes
Global
1999-2015
Optimization of Inventory at 2 legal entities with various warehouses/storage locations
Switzerland
1999-2015
Optimization of Inventory at 5 legal entities with various warehouses/storage locations
Global
2013-2015
Introducing NPI (New Product Introduction) System with SAP data (CAD, BOM, MM, etc)
Global
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.
Global
2014-2015
Transfer of a complete product line (production, procurement, order processing, logistics) from Switzerland to USA
Switzerland /USA
2014-2015
Transfer of a complete product line (production, procurement, order processing, logistics) from US to Switzerland
Switzerland /USA
2014-2015
Conversion of all devices produced in Switzerland to meet European RoHS directive and the US Conflict Minerals directive
Switzerland
2014
Establishing a global matrix organization for manufacturing engineering.
Global
2012 - 2014
Insourcing of complete production for electromechanical products
EMEA
2012 - 2014
Implementation of a global return and repair (RMA) tool using SAP
Global
2011 - 2012
Analysis and evaluation of potential manufacturers as well as subsequent implementation of a supply chain in Malaysia and China
APAC
2010 - 2012
Implementation of Asset Management in SAP
Switzerland
2009 - 2010
SAP worldwide harmonization and synchronization as well as an upgrade to ECC6.0 including all data cleansing activities, testing and documentation
Global
2009
Re-organization of operational organization including Purchasing, Planning, Manufacturing Engineering, Order Processing, Logistics, Computer Systems, Project Management and Finance
Switzerland
2008
Implementation of Business Controlling with use of SAP data
Switzerland
2006 ? 2008
Implementation of SAP Document Management System
Global
2007
Evaluation and integration of various 3rd party outsourcing partners
Global
2006
Implementation of SAP R3 as ERP System
Switzerland
2004 - 2005
Change of logistics set up from internal solution to an external one
Switzerland
2000 - 2015
Re-organization of the teams ?production? and ?purchasing & planning?
Switzerland
2004
Selection of Tools developed for these Projects:
Remarks: All Tools do have an interface to SAP and can use the data directly from the database.
Tools
Creation of a process- and material flow chart: as an overview and also for preparation (Validation, Audit, etc.)
Comparison of planned purchasing value vs. Planned shipping value: helps to optimize inventory value and cash flow
Automated system to detect early and late goods receipt at warehouses and supplier stocks: helps to optimize inventory value and cash flow
Country of Origin: calculates country of origin and other custom relevant figures with HS-Code, Tariffs etc.
?Multi Echelon Inventory Optimization? equivalent Tool: Optimizes inventory, transportation, service levels etc.
Device Master Record: Create DMR using existing SAP Data (MM, BOM, etc.)
Test Reporting: Test Result Evaluation for FAT, tests, etc.
------------------------------------------------------------------------------------------------------------------------------------------
------------------------------------------------------------------------------------------------------------------------------------------
Experience in Risk Assessment, Risk Mitigation, Verification, Validation und Qualification
Reto Hauri
CEO & Chairman, Projectmanager
All listed projects have been elaborated and performed according to Quality System Regulations (QSR), 21CFR820, 21CFR11, ISO13485, GxP and GAMP regulations and methods.
The projects included Systems, Products, Processes, Test-methods and Suppliers:
Most of these activities have been done for a Medical Device Manufacturer (market leader in its segment) at its headquarter or subsidiaries in following countries:
Selection from Projects:
Risk Assessment & Mitigation Plan
Project
Where
When
Suppliers & Processes for Subcontracting (Outsourced Manufacturing) at 3rd Party Suppliers
Global
1999-2015
Manufacturing Processes
Global
1999-2015
Packaging
Global
1999-2015
Test Equipment
Global
1999-2015
Computer Systems
Global
1999-2015
Qualification
Project
Where
When
System for Hard disk Duplication
Switzerland
2014
System for CD and DVD Duplication
Switzerland
2005
Test systems for Component and Assembly Tests
Global
1999-2015
Arendar System (test management system)
Switzerland
2007
SAP Systems and Add-ons
Global
1999-2015
MS Access, Excel (VBA) and VB.net based Systems
Global
1999-2015
Computersystems at test equipments
Switzerland
1999-2015
Verification
Project
Where
When
Processes for Subcontracting (Outsourced Manufacturing) at 3rd Party Suppliers (e.g. Cables, Harnesses, Electronics, PCBAs, Mechanics?)
Global
1999-2015
Validation
Project
Where
When
Computer Systems
Global
1999-2015
Test processes (automated, semi-automated)
Switzerland
1999-2015
Heatsealing processes
Global
1999-2015
Gluing processes
Switzerland
1999-2015
Packaging
Global
1999-2015
Welding processes
Global
1999-2015
Sterilisation processes
Germany
2014
General
Project
Where
When
Elaboration of a global Supplier Management Process inclusive Procurement, Risk management, Validation etc.
Global
2014-2015
Pharma
Medical Devices
High Tech
Multiple Projects such as:
- MDR Uplift for Heart Lung Machines (Class IIb) and Heater Cooler Units
-Product Transfer from USA/Sweden to Germany
- Reliability calculations and tests
consult investment companies in medical devices, mainly radiation therapy
2016-heute (Medical Devices)
Business Analysis. FDA Consultant (Remediation Project). Coach for R&D Department. Proxy of Director R&D, CSV
2015- heute (HighTech Company)
Configuration Management, PLM, Software Anpassungen
Business Analysis. Implementation of configuration strategy, establish configuration and implement Product Lifecycle Management Tool. Computer System Validation.
2015 - heute (Investment Companies)
Beratung von Investment Firmen im Bereich Radioonkologie und Laserpositioniersysteme
2015- 2017 (Pharma / Medical Devices)
DHF Prozess Implementation, PLM Tool Evaluation & Configuration
2014 - 2015
Einführung eines NPI (New Product Introduction) Systems mit SAP Daten (CAD, BOM, MM, etc.)
2014 - heute
Erarbeiten und Einführen eines globalen Lieferantenmanagement-prozesses inclusive Commodity Strategie, Low Cost Country Strategie, Inventar Optimierung, sowie allgemeine Verbesserung der Prozesse. Alle Prozesse und Dokumente wurden ISO 13485 und FDA QSR 21CFR820 und Part11 konform erstellt.
2014
Transfer einer kompletten Produktlinie (inclusive Produktion, Outsourcing, Beschaffung, Auftragsabwicklung, Manufacturing Engineering und Logistik) aus der Schweiz in die USA
2012 - 2014
Transfer einer kompletten Produktlinie (inclusive Produktion, Outsourcing, Beschaffung, Auftragsabwicklung, Manufacturing Engineering und Logistik) aus den USA in die Schweiz und EU.
2012 - 2014
Umstellung und Anpassung aller in der Schweiz gefertigter Komponenten und Produkte, so dass sie konform der Europäischen RoHS Direktive und der US Conflict Minerals Direktive sind
2011 - 2012
Erarbeitung und Aufstellung einer globalen Matrixorganisation für Manufacturing Engineering.
2010 - 2012
Insourcing der kompletten Produktionssteuerung und ?Abwicklung für mechanische Produkte und Komponenten.
2009 - 2010
Erarbeiten und Einführen eines globale Retouren- und Reparaturenmanagementprozesses (RMA) und entwickeln der Prozesse für SAP
2009
Analyse der Marktsituationen für Beschaffung, Evaluation möglicher Hersteller sowie die Einführung einer Supply Chain in Malaysia und China
2008
Einführung von Asset Management in SAP (für Anlagevermögen)
2006 ? 2008
Weltweite SAP Harmonisierung und Synchronisation, sowie ein Upgrade auf SAP ECC6.0 inklusive Datenbereinigung, Tests, Dokumentation und Anwendertrainings.
2007
Re-organisation der operative Organisation (Beschaffung, Planung, Manufacturing Engineering, Auftragsabwicklung, Logistik, Computer Systeme, Projektmanagement und Finanz/Controlling).
2006
Einführung eines Controlling Systems für das operative Business mit SAP Daten.
2004 - 2005
Einführung eines Dokumenten Managementsystems in SAP
2000 - heute
Evaluierung und Integration mehrerer Outsourcing Partner weltweit
2004
Einführung von SAP R3 als ERP System
2000
Änderung der Logistik und der Lagerhaltung von interner zu externer Lösung
1999
Reorganisation der Teams ?Produktion? und ?Beschaffung und Planung
1993 -1999
Verschiedenste Entwicklungsprojekte für Geräte und Maschinen inklusive deren Bau, Test und Benutzerschulungen.
Experience in Logistics and Supply Chain Management
Reto Hauri
CEO & Chairman, Projectmanager
All listed projects have been elaborated and performed according to Quality System Regulations (QSR), 21CFR820, 21CFR11, ISO13485, GxP and GAMP regulations and methods..
Selection from Projects:
Project
Where
When
Management of Logistics and Procurement Groups
Global
1999-2015
Subcontracting (Outsourced Manufacturing) at 3rd Party Suppliers
Global
1999-2015
Improvinng and Optimizing of Supply Chain and Logistics Processes
Global
1999-2015
Optimization of Inventory at 2 legal entities with various warehouses/storage locations
Switzerland
1999-2015
Optimization of Inventory at 5 legal entities with various warehouses/storage locations
Global
2013-2015
Introducing NPI (New Product Introduction) System with SAP data (CAD, BOM, MM, etc)
Global
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.
Global
2014-2015
Transfer of a complete product line (production, procurement, order processing, logistics) from Switzerland to USA
Switzerland /USA
2014-2015
Transfer of a complete product line (production, procurement, order processing, logistics) from US to Switzerland
Switzerland /USA
2014-2015
Conversion of all devices produced in Switzerland to meet European RoHS directive and the US Conflict Minerals directive
Switzerland
2014
Establishing a global matrix organization for manufacturing engineering.
Global
2012 - 2014
Insourcing of complete production for electromechanical products
EMEA
2012 - 2014
Implementation of a global return and repair (RMA) tool using SAP
Global
2011 - 2012
Analysis and evaluation of potential manufacturers as well as subsequent implementation of a supply chain in Malaysia and China
APAC
2010 - 2012
Implementation of Asset Management in SAP
Switzerland
2009 - 2010
SAP worldwide harmonization and synchronization as well as an upgrade to ECC6.0 including all data cleansing activities, testing and documentation
Global
2009
Re-organization of operational organization including Purchasing, Planning, Manufacturing Engineering, Order Processing, Logistics, Computer Systems, Project Management and Finance
Switzerland
2008
Implementation of Business Controlling with use of SAP data
Switzerland
2006 ? 2008
Implementation of SAP Document Management System
Global
2007
Evaluation and integration of various 3rd party outsourcing partners
Global
2006
Implementation of SAP R3 as ERP System
Switzerland
2004 - 2005
Change of logistics set up from internal solution to an external one
Switzerland
2000 - 2015
Re-organization of the teams ?production? and ?purchasing & planning?
Switzerland
2004
Selection of Tools developed for these Projects:
Remarks: All Tools do have an interface to SAP and can use the data directly from the database.
Tools
Creation of a process- and material flow chart: as an overview and also for preparation (Validation, Audit, etc.)
Comparison of planned purchasing value vs. Planned shipping value: helps to optimize inventory value and cash flow
Automated system to detect early and late goods receipt at warehouses and supplier stocks: helps to optimize inventory value and cash flow
Country of Origin: calculates country of origin and other custom relevant figures with HS-Code, Tariffs etc.
?Multi Echelon Inventory Optimization? equivalent Tool: Optimizes inventory, transportation, service levels etc.
Device Master Record: Create DMR using existing SAP Data (MM, BOM, etc.)
Test Reporting: Test Result Evaluation for FAT, tests, etc.
------------------------------------------------------------------------------------------------------------------------------------------
------------------------------------------------------------------------------------------------------------------------------------------
Experience in Risk Assessment, Risk Mitigation, Verification, Validation und Qualification
Reto Hauri
CEO & Chairman, Projectmanager
All listed projects have been elaborated and performed according to Quality System Regulations (QSR), 21CFR820, 21CFR11, ISO13485, GxP and GAMP regulations and methods.
The projects included Systems, Products, Processes, Test-methods and Suppliers:
Most of these activities have been done for a Medical Device Manufacturer (market leader in its segment) at its headquarter or subsidiaries in following countries:
Selection from Projects:
Risk Assessment & Mitigation Plan
Project
Where
When
Suppliers & Processes for Subcontracting (Outsourced Manufacturing) at 3rd Party Suppliers
Global
1999-2015
Manufacturing Processes
Global
1999-2015
Packaging
Global
1999-2015
Test Equipment
Global
1999-2015
Computer Systems
Global
1999-2015
Qualification
Project
Where
When
System for Hard disk Duplication
Switzerland
2014
System for CD and DVD Duplication
Switzerland
2005
Test systems for Component and Assembly Tests
Global
1999-2015
Arendar System (test management system)
Switzerland
2007
SAP Systems and Add-ons
Global
1999-2015
MS Access, Excel (VBA) and VB.net based Systems
Global
1999-2015
Computersystems at test equipments
Switzerland
1999-2015
Verification
Project
Where
When
Processes for Subcontracting (Outsourced Manufacturing) at 3rd Party Suppliers (e.g. Cables, Harnesses, Electronics, PCBAs, Mechanics?)
Global
1999-2015
Validation
Project
Where
When
Computer Systems
Global
1999-2015
Test processes (automated, semi-automated)
Switzerland
1999-2015
Heatsealing processes
Global
1999-2015
Gluing processes
Switzerland
1999-2015
Packaging
Global
1999-2015
Welding processes
Global
1999-2015
Sterilisation processes
Germany
2014
General
Project
Where
When
Elaboration of a global Supplier Management Process inclusive Procurement, Risk management, Validation etc.
Global
2014-2015
Pharma
Medical Devices
High Tech
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