• 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.

• 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.

• 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

• 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

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

• 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

• 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

• 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

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

• Imaging & Therapy Division
• External consultant for the sector Oncology Care Systems in Heidelberg and Erlangen

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

PMO Assistant in a German/French/Japanese large-scale project with BASF, Ludwigshafen

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

Terminal Care and Relative Care