Process Optimization of the Product Change Management Process
Interim Change Manager and BU Coach
Interim Change Manager and BU Coach
Dürr Dental SE
Bietigheim-Bissingen
1 Jahr 4 Monate
2022-03 - 2023-06
Review of open Process Documentation Change Requests
Interim Quality Systems Engineer
Interim Quality Systems Engineer
Review of open Process Documentation Change Requests (DOC-CRs) and CAPAs for the processing status
Review of the affected processes to see whether the changes have already been implemented.
Consultation with the process owners and departments involved in processing/closing the applications.
For periodic reviews, consultation with the process owners to complete the review.
Independent follow-up of defined measures
Regular reporting of the processing status to the QA team management.
Getinge Deutschland GmbH
Rastatt / Hechingen
4 Monate
2023-01 - 2023-04
Interim Lifecycle Management
Revision, documentation, and closure of Lifecycle Tickets
Review of lifecycle tickets for compliance with Regulations and QM specifications
Development of the required verification documents for the documentation of changes within the framework of Lifecycle Management
Processing of specification and verification documents for the CZM document database.
Carl Zeiss Meditec AG
Jena
4 Monate
2020-09 - 2020-12
QMS Simplification Program
Interim Change Manager
Interim Change Manager
QMS process optimization in terms of comprehensibility, transparency and responsibilities.
Coordination of the necessary analyzes of the value stream, the impact on compliance and the dependencies on the CAPA process (Corrective and Preventive Actions)
Stakeholder support (e.g. Management, R&D, Q&R, manufacturing) in regard of implementation and rollout management
Planning and moderation of the strategy, analysis and result meetings
Advise in the development of technical solutions in regard to content, usability and comprehensibility
Coaching and training on how to use the new solution
Development of a QMS communication platform to ensure and simplify the flow of information
Further sub-projects regarding management of internal communication in the QMS and affected interfaces as well as NPSS
Philips Medical Systems Böblingen GmbH
1 Jahr 1 Monat
2019-09 - 2020-09
SPO2 Sensor Family and IntelliVue Guardian Solution SW(IGS)
Interims Product Quality Engineer (PQE)
Interims Product Quality Engineer (PQE)
Responsible PQE for accompanying the manufacturing relocation of the SPO2 Sensor Family
Responsible PQE for EU MDR update for the IntelliVue Guardian Solution software and SPO2 cables
Review and approval of project milestone results based on project planning
DHF Review Lead
Evaluation, analysis of complaints, review of the Postmarket Surveillance Plans and Reports
Member of Cross Functional Team and Change planning meetings
Support and coaching of the PQE team and the cross-functional teams in the event of bottlenecks such as EC reviews, review of process updates, participation in change planning meetings or audit preparation
Close cooperation and exchange of information with all PQE interfaces involved, especially Suppliers QE and manufacturing QE
Philips Medical Systems Böblingen GmbH
1 Jahr 4 Monate
2017-11 - 2019-02
Global Change Management
Interim Manager
Interim Manager
Introduction, implementation, and optimization of the change management process under consideration of DIN EN ISO 13485_2016 and FDA 21 CFR Part 820 guidelines
Review and restructuring of the complete Product Change Management Process including SOPs , Work instructions and Trainings
Establishment of the phases Change Description, Change plan, Change report and implementation of interdepartmental checklists within the new Database
Control and monitoring of product and process change requests
Identification of the responsibilities / tasks of the individual departments / roles and stakeholder within change management
Linking the new change management process with the newly introduced PLM process
Development of a constructive cooperation with all interfaces within change management
Improving the understanding of what changes in medica grade products mean
Coaching of the production change coordinator
Dürr Dental SE
Bietigheim-Bissingen
1 Jahr 2 Monate
2016-04 - 2017-05
new Insulin Delivery System
Technical Project Lead Quality / Design Quality Manager
Technical Project Lead Quality / Design Quality Manager
Head of the project quality team (9 persons), responsible for budget planning
Responsible for all quality aspects in compliance with regulatory guidelines
Project Core Team Member, providing the monthly quality status reports
Ensure timely and compliant deployment of quality deliverables of all quality departments: quality planning, risk management, process validation, supplier quality management, inspection planning, change management and complaint handling
Ensuring compliance with the processes relevant for IDS Mannheim
Coordination and support of quality departments and all subprojects in providing the results of their work
Moderation of the risk analysis meetings
Review and approval of all project/product related specifications and documents
Creation and update of Essential Requirements Checklists (ERCL): MD Directive 93/42/EC, RED2014/53/EU, Packaging and Packaging Waste Directive 94/62/EC, IVD Directive 98/79/EC for the projects and their related studies
Member of the system issue tracking board, all change boards (system and subsystem), technical synchronization meeting, launch preparation working group, label und packaging group
Roche Diabetes Care GmbH
Mannheim
7 Monate
2015-08 - 2016-02
IT process restructuring
Change Consultant /Project Manager
Change Consultant /Project Manager
IT process restructuring within the framework of ITIL introduction
Analysis and definition of the demand management workflow
Introduction of JIRA
Coaching / task restructuring for the Business Relationship Managers and the Business Unit IT Coordinator
DKMS GmbH
Tübingen
7 Monate
2015-01 - 2015-07
E (Q) Valuation
General Manager
General Manager
Consulting, design and conduction of horse guided executive and team coaching
?E (Q) Valuation? for performance feedback evaluation, team building and executive coaching and training
ESTRO Foundation
Belgium
6 Jahre
2007-05 - 2013-04
Change Management Process for Quality Assurance
Manager, Project Change Control Board Moderator
Manager, Project Change Control Board Moderator
Change Management Process for Quality Assurance in the Software and System Development
SW / HW system development projects for oncology care systems, responsible for Heidelberg, Erlangen, Forchheim, Concord - USA, Bangalore - India and Kosice ? Slovakia
Analysis and restructuring of the change request management process after development relocation from USA to Germany
Introduction / compliance with risk analysis criteria in the assessment of deviations / errors / issues
Development of RA templates
Responsible process owner and trainer
Database Administrator
Project consultant advising new development projects
Preparation of milestone reviews
Set-up of the CAPA process in a tracking tool
Responsible for up to 18 projects at the same time
Heidelberg, Erlangen, Forchheim, Concord - USA, Bangalore - India and Kosice ? Slovakia
7 Jahre 11 Monate
2005-05 - 2013-03
Oncology Care Systems
External consultant
External consultant
Imaging & Therapy Division
External consultant for the sector Oncology Care Systems in Heidelberg and Erlangen
Siemens AG, Healthcare Sector
Heidelberg, Erlangen
2 Jahre
2005-05 - 2007-04
Development and Implementation of a Customer and Training Center
Project Manager
Project Manager
Development and Implementation of a Customer and Training Center for Siemens Medical Solutions, Oncology Care Systems
Conception, implementation and coordination of the Customer and Training Center
Organization of conferences in cooperation with the DKFZ Heidelberg (Deutsches Krebsforschungszentrum) and HIT (Heidelberger Ionenstrahl Therapiezentrum)
Organization and evaluation of internal trainings
Execution of intercultural trainings for Indian employees
Siemens Medical Solutions
Heidelberg
1 Jahr 2 Monate
2004-02 - 2005-03
various Projects
Team and Executive Assistant
Team and Executive Assistant
Siemens AG, Medical Solutions, OCS
Heidelberg
10 Monate
2003-02 - 2003-11
German/French/Japanese large-scale project
PMO Assistant
PMO Assistant
PMO Assistant in a German/French/Japanese large-scale project with BASF, Ludwigshafen
Technip Germany GmbH, Randstad Deutschland GmbH & Co. KG, BASF
Düsseldorf, Ludwigshafen
11 Monate
2002-04 - 2003-02
employed
International HR Assistant
International HR Assistant
SAP AG, Randstad Deutschland GmbH & Co. KG
Walldorf
9 Monate
2001-02 - 2001-10
Emergency Response Information Center (ERIC)
Project collaborator in the department for Emergency Management
Responsible for the recruitment, selection, and training of employees in the Emergency Information Centre
Concept development of training contents
Design of a database for the Emergency Information Centre
Fraport AG
Frankfurt am Main
2 Jahre 11 Monate
1998-03 - 2001-01
Terminal Care and Relative Care
Assistant Nurse
Assistant Nurse
Terminal Care and Relative Care
Heidelberger Hauspflege e.V.
11 Jahre 11 Monate
1986-04 - 1998-02
employed
Assistant Nurse
Assistant Nurse
Bethesda Krankenhaus
Stuttgart
5 Jahre 9 Monate
1990-07 - 1996-03
employed
Assistant Nurse
Assistant Nurse
Klinikum Universität
Heidelberg
Aus- und Weiterbildung
Aus- und Weiterbildung
10 Jahre 9 Monate
1990-04 - 2000-12
Science of Education, Psychology, Philosophy
Magister Artium, Ruprecht Karls University of Heidelberg
Magister Artium
Ruprecht Karls University of Heidelberg
Certification
Internal Auditor ISO 13485 (DQG)
Risk Management (TÜV Süd)
Usability & IEC (Johner Institute)
Six Sigma Green Belt training & Project Management for Lean Six Sigma Projects (Six Sigma Academy Amsterdam)
Systemic Coach & Consultant
Prosci® Change-Manager
Kompetenzen
Kompetenzen
Top-Skills
Expert Quality Management ISO 13485EU MDR 2017/ 745 & IVDR 2017/ 746Systemic Coach and ConsultantPROCI Change Manager
Schwerpunkte
Senior Project & Change Management
Quality Management
Change Control & CAPA Management
Medical Devices Companies
Produkte / Standards / Erfahrungen / Methoden
Personal Skills:
Analytical
result-oriented
communicative
hands on personality
transparent
Tools
IBM Rational Clear Quest
IBM Rational Clear Case
HP Quality Center
Veeva Vault Quality
SAP R/3
IFS
SharePoint
MS Office (Word, Excel, PowerPoint, Outlook)
Jira 6.4
Einsatzorte
Einsatzorte
Deutschland, Schweiz, Österreich
möglich
Projekte
Projekte
1 Jahr 2 Monate
2023-07 - heute
Process Optimization of the Product Change Management Process
Interim Change Manager and BU Coach
Interim Change Manager and BU Coach
Dürr Dental SE
Bietigheim-Bissingen
1 Jahr 4 Monate
2022-03 - 2023-06
Review of open Process Documentation Change Requests
Interim Quality Systems Engineer
Interim Quality Systems Engineer
Review of open Process Documentation Change Requests (DOC-CRs) and CAPAs for the processing status
Review of the affected processes to see whether the changes have already been implemented.
Consultation with the process owners and departments involved in processing/closing the applications.
For periodic reviews, consultation with the process owners to complete the review.
Independent follow-up of defined measures
Regular reporting of the processing status to the QA team management.
Getinge Deutschland GmbH
Rastatt / Hechingen
4 Monate
2023-01 - 2023-04
Interim Lifecycle Management
Revision, documentation, and closure of Lifecycle Tickets
Review of lifecycle tickets for compliance with Regulations and QM specifications
Development of the required verification documents for the documentation of changes within the framework of Lifecycle Management
Processing of specification and verification documents for the CZM document database.
Carl Zeiss Meditec AG
Jena
4 Monate
2020-09 - 2020-12
QMS Simplification Program
Interim Change Manager
Interim Change Manager
QMS process optimization in terms of comprehensibility, transparency and responsibilities.
Coordination of the necessary analyzes of the value stream, the impact on compliance and the dependencies on the CAPA process (Corrective and Preventive Actions)
Stakeholder support (e.g. Management, R&D, Q&R, manufacturing) in regard of implementation and rollout management
Planning and moderation of the strategy, analysis and result meetings
Advise in the development of technical solutions in regard to content, usability and comprehensibility
Coaching and training on how to use the new solution
Development of a QMS communication platform to ensure and simplify the flow of information
Further sub-projects regarding management of internal communication in the QMS and affected interfaces as well as NPSS
Philips Medical Systems Böblingen GmbH
1 Jahr 1 Monat
2019-09 - 2020-09
SPO2 Sensor Family and IntelliVue Guardian Solution SW(IGS)
Interims Product Quality Engineer (PQE)
Interims Product Quality Engineer (PQE)
Responsible PQE for accompanying the manufacturing relocation of the SPO2 Sensor Family
Responsible PQE for EU MDR update for the IntelliVue Guardian Solution software and SPO2 cables
Review and approval of project milestone results based on project planning
DHF Review Lead
Evaluation, analysis of complaints, review of the Postmarket Surveillance Plans and Reports
Member of Cross Functional Team and Change planning meetings
Support and coaching of the PQE team and the cross-functional teams in the event of bottlenecks such as EC reviews, review of process updates, participation in change planning meetings or audit preparation
Close cooperation and exchange of information with all PQE interfaces involved, especially Suppliers QE and manufacturing QE
Philips Medical Systems Böblingen GmbH
1 Jahr 4 Monate
2017-11 - 2019-02
Global Change Management
Interim Manager
Interim Manager
Introduction, implementation, and optimization of the change management process under consideration of DIN EN ISO 13485_2016 and FDA 21 CFR Part 820 guidelines
Review and restructuring of the complete Product Change Management Process including SOPs , Work instructions and Trainings
Establishment of the phases Change Description, Change plan, Change report and implementation of interdepartmental checklists within the new Database
Control and monitoring of product and process change requests
Identification of the responsibilities / tasks of the individual departments / roles and stakeholder within change management
Linking the new change management process with the newly introduced PLM process
Development of a constructive cooperation with all interfaces within change management
Improving the understanding of what changes in medica grade products mean
Coaching of the production change coordinator
Dürr Dental SE
Bietigheim-Bissingen
1 Jahr 2 Monate
2016-04 - 2017-05
new Insulin Delivery System
Technical Project Lead Quality / Design Quality Manager
Technical Project Lead Quality / Design Quality Manager
Head of the project quality team (9 persons), responsible for budget planning
Responsible for all quality aspects in compliance with regulatory guidelines
Project Core Team Member, providing the monthly quality status reports
Ensure timely and compliant deployment of quality deliverables of all quality departments: quality planning, risk management, process validation, supplier quality management, inspection planning, change management and complaint handling
Ensuring compliance with the processes relevant for IDS Mannheim
Coordination and support of quality departments and all subprojects in providing the results of their work
Moderation of the risk analysis meetings
Review and approval of all project/product related specifications and documents
Creation and update of Essential Requirements Checklists (ERCL): MD Directive 93/42/EC, RED2014/53/EU, Packaging and Packaging Waste Directive 94/62/EC, IVD Directive 98/79/EC for the projects and their related studies
Member of the system issue tracking board, all change boards (system and subsystem), technical synchronization meeting, launch preparation working group, label und packaging group
Roche Diabetes Care GmbH
Mannheim
7 Monate
2015-08 - 2016-02
IT process restructuring
Change Consultant /Project Manager
Change Consultant /Project Manager
IT process restructuring within the framework of ITIL introduction
Analysis and definition of the demand management workflow
Introduction of JIRA
Coaching / task restructuring for the Business Relationship Managers and the Business Unit IT Coordinator
DKMS GmbH
Tübingen
7 Monate
2015-01 - 2015-07
E (Q) Valuation
General Manager
General Manager
Consulting, design and conduction of horse guided executive and team coaching
?E (Q) Valuation? for performance feedback evaluation, team building and executive coaching and training
ESTRO Foundation
Belgium
6 Jahre
2007-05 - 2013-04
Change Management Process for Quality Assurance
Manager, Project Change Control Board Moderator
Manager, Project Change Control Board Moderator
Change Management Process for Quality Assurance in the Software and System Development
SW / HW system development projects for oncology care systems, responsible for Heidelberg, Erlangen, Forchheim, Concord - USA, Bangalore - India and Kosice ? Slovakia
Analysis and restructuring of the change request management process after development relocation from USA to Germany
Introduction / compliance with risk analysis criteria in the assessment of deviations / errors / issues
Development of RA templates
Responsible process owner and trainer
Database Administrator
Project consultant advising new development projects
Preparation of milestone reviews
Set-up of the CAPA process in a tracking tool
Responsible for up to 18 projects at the same time
Heidelberg, Erlangen, Forchheim, Concord - USA, Bangalore - India and Kosice ? Slovakia
7 Jahre 11 Monate
2005-05 - 2013-03
Oncology Care Systems
External consultant
External consultant
Imaging & Therapy Division
External consultant for the sector Oncology Care Systems in Heidelberg and Erlangen
Siemens AG, Healthcare Sector
Heidelberg, Erlangen
2 Jahre
2005-05 - 2007-04
Development and Implementation of a Customer and Training Center
Project Manager
Project Manager
Development and Implementation of a Customer and Training Center for Siemens Medical Solutions, Oncology Care Systems
Conception, implementation and coordination of the Customer and Training Center
Organization of conferences in cooperation with the DKFZ Heidelberg (Deutsches Krebsforschungszentrum) and HIT (Heidelberger Ionenstrahl Therapiezentrum)
Organization and evaluation of internal trainings
Execution of intercultural trainings for Indian employees
Siemens Medical Solutions
Heidelberg
1 Jahr 2 Monate
2004-02 - 2005-03
various Projects
Team and Executive Assistant
Team and Executive Assistant
Siemens AG, Medical Solutions, OCS
Heidelberg
10 Monate
2003-02 - 2003-11
German/French/Japanese large-scale project
PMO Assistant
PMO Assistant
PMO Assistant in a German/French/Japanese large-scale project with BASF, Ludwigshafen
Technip Germany GmbH, Randstad Deutschland GmbH & Co. KG, BASF
Düsseldorf, Ludwigshafen
11 Monate
2002-04 - 2003-02
employed
International HR Assistant
International HR Assistant
SAP AG, Randstad Deutschland GmbH & Co. KG
Walldorf
9 Monate
2001-02 - 2001-10
Emergency Response Information Center (ERIC)
Project collaborator in the department for Emergency Management
Responsible for the recruitment, selection, and training of employees in the Emergency Information Centre
Concept development of training contents
Design of a database for the Emergency Information Centre
Fraport AG
Frankfurt am Main
2 Jahre 11 Monate
1998-03 - 2001-01
Terminal Care and Relative Care
Assistant Nurse
Assistant Nurse
Terminal Care and Relative Care
Heidelberger Hauspflege e.V.
11 Jahre 11 Monate
1986-04 - 1998-02
employed
Assistant Nurse
Assistant Nurse
Bethesda Krankenhaus
Stuttgart
5 Jahre 9 Monate
1990-07 - 1996-03
employed
Assistant Nurse
Assistant Nurse
Klinikum Universität
Heidelberg
Aus- und Weiterbildung
Aus- und Weiterbildung
10 Jahre 9 Monate
1990-04 - 2000-12
Science of Education, Psychology, Philosophy
Magister Artium, Ruprecht Karls University of Heidelberg
Magister Artium
Ruprecht Karls University of Heidelberg
Certification
Internal Auditor ISO 13485 (DQG)
Risk Management (TÜV Süd)
Usability & IEC (Johner Institute)
Six Sigma Green Belt training & Project Management for Lean Six Sigma Projects (Six Sigma Academy Amsterdam)
Systemic Coach & Consultant
Prosci® Change-Manager
Kompetenzen
Kompetenzen
Top-Skills
Expert Quality Management ISO 13485EU MDR 2017/ 745 & IVDR 2017/ 746Systemic Coach and ConsultantPROCI Change Manager
Schwerpunkte
Senior Project & Change Management
Quality Management
Change Control & CAPA Management
Medical Devices Companies
Produkte / Standards / Erfahrungen / Methoden
Personal Skills:
Analytical
result-oriented
communicative
hands on personality
transparent
Tools
IBM Rational Clear Quest
IBM Rational Clear Case
HP Quality Center
Veeva Vault Quality
SAP R/3
IFS
SharePoint
MS Office (Word, Excel, PowerPoint, Outlook)
Jira 6.4
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