Quality Manager / Product Change Manager/ Project Manager Medizintechnik
Aktualisiert am 01.03.2024
Profil
Freiberufler / Selbstständiger
Remote-Arbeit
Verfügbar ab: 01.03.2024
Verfügbar zu: 100%
davon vor Ort: 100%
Expert Quality Management ISO 13485
EU MDR 2017/ 745 & IVDR 2017/ 746
Systemic Coach and Consultant
PROCI Change Manager
English
fluent
French
basic communication skills
Portuguese
basic communication skills
Italian:
basic communication skills
German
Muttersprache

Einsatzorte

Einsatzorte

Deutschland, Schweiz, Österreich
möglich

Projekte

Projekte

4 Monate
2020-09 - 2020-12

QMS process optimization

Subproject Manager QMS Simplification Program
Subproject Manager QMS Simplification Program

  • 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

Consultant Project Manager
Consultant Project Manager

  • Consultant Project Manager for 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

Manager Change Management Process

Project Change Control Board Moderator
Project Change Control Board Moderator

  • Manager Change Management Process for Quality Assurance in the Software and System Development
  • Project Change Control Board Moderator of all 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

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

employed

Team and Executive Assistant
Team and Executive Assistant
Siemens AG, Medical Solutions, OCS, Randstad Deutschland GmbH & Co. KG
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

Kompetenzen

Kompetenzen

Top-Skills

Expert Quality Management ISO 13485 EU MDR 2017/ 745 & IVDR 2017/ 746 Systemic Coach and Consultant PROCI Change Manager

Produkte / Standards / Erfahrungen / Methoden

IT Knowledge:

  • MS Office (Word, Excel, PowerPoint, Outlook)
  • Jira 6.4
  • IBM Rational Clear Quest, IBM Rational Clear Case
  • HP Quality Center
  • SAP R/3
  • Sharepoin


Relevant knowledge:

  • Systemic Coach and Consultant
  • Project Management for Lean SiX Sigma Projects
  • Internal Auditor ISO 13485 (DQG)
  • EU MDR 2017/ 745 & IVDR 2017/ 746
  • QMS Auditor / Lead Auditor (QG Quality Gurus)
  • Risk Management 14971 (TÜV Süd)
  • Usability & IEC 62366-1: 2015 (Johner Institute)
  • Six Sigma Green Belt training
  • Project Management for Lean Six Sigma Projects (SixSigmaAcademyAmsterdam)
  • IEC 62366-1, IEC 62304, IEC 60601/61010 und IEC 82304-1 (Training on the job) Projects


Professional Focus:

Project Management, Change Management and Quality Management within Medical Devices Companies


Personal Skills:

Analytical, result-oriented, communicative, transparent, and trusting

Einsatzorte

Einsatzorte

Deutschland, Schweiz, Österreich
möglich

Projekte

Projekte

4 Monate
2020-09 - 2020-12

QMS process optimization

Subproject Manager QMS Simplification Program
Subproject Manager QMS Simplification Program

  • 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

Consultant Project Manager
Consultant Project Manager

  • Consultant Project Manager for 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

Manager Change Management Process

Project Change Control Board Moderator
Project Change Control Board Moderator

  • Manager Change Management Process for Quality Assurance in the Software and System Development
  • Project Change Control Board Moderator of all 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

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

employed

Team and Executive Assistant
Team and Executive Assistant
Siemens AG, Medical Solutions, OCS, Randstad Deutschland GmbH & Co. KG
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

Kompetenzen

Kompetenzen

Top-Skills

Expert Quality Management ISO 13485 EU MDR 2017/ 745 & IVDR 2017/ 746 Systemic Coach and Consultant PROCI Change Manager

Produkte / Standards / Erfahrungen / Methoden

IT Knowledge:

  • MS Office (Word, Excel, PowerPoint, Outlook)
  • Jira 6.4
  • IBM Rational Clear Quest, IBM Rational Clear Case
  • HP Quality Center
  • SAP R/3
  • Sharepoin


Relevant knowledge:

  • Systemic Coach and Consultant
  • Project Management for Lean SiX Sigma Projects
  • Internal Auditor ISO 13485 (DQG)
  • EU MDR 2017/ 745 & IVDR 2017/ 746
  • QMS Auditor / Lead Auditor (QG Quality Gurus)
  • Risk Management 14971 (TÜV Süd)
  • Usability & IEC 62366-1: 2015 (Johner Institute)
  • Six Sigma Green Belt training
  • Project Management for Lean Six Sigma Projects (SixSigmaAcademyAmsterdam)
  • IEC 62366-1, IEC 62304, IEC 60601/61010 und IEC 82304-1 (Training on the job) Projects


Professional Focus:

Project Management, Change Management and Quality Management within Medical Devices Companies


Personal Skills:

Analytical, result-oriented, communicative, transparent, and trusting

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