Senior quality assurance and processes expert
Keywords : Medical device, SW, services and project management, Team management
ISO13485 - ISO14971 - IEC62304 - IEC 62366
Excellence, amélioration continue
CMMi, TopoMaintenance, TMA
Medical device - Process and QA officer Louvain-la-Neuve, Ottignies-Louvain-la-Neuve, Belgium
February 2011 --- August 2015
- Realization and implementation of a “Quality Management System”: writing of a set of project management and development processes, according to international standards (ISO 14971, ISO 13485, IEC 62304, IEC 62366) in order to improve organization and efficiency.
- Training / coaching of the team on the processes.
- Quality management: verification of the use of the defined processes by the team; audits, definition of indicators / KPIs and follow-up; reports, corrective actions; processes improvements.
- Change management: change control board and change management process.
- Participation to the realization of the certification file and to the verification and validation activities.
- Quality manager for the document validation process (using the Metadoc tool)
- Administrator of the Redmine application (follow-up of realizations, documents sharing…) including the Wiki. End-users training (technical writing and instruction).
Excellence driver - Process and services manager
September 2002 --- January 2011
Arcelor Liège - Driver for “Excellence approach” - TOPOMaintenance
- Study of working habits and improvement proposals to reduce cost, effort and time by description and improvement of work processes, root cause analysis, “one point lessons”, team coaching, training plan…
- Definition of KPIs and follow-up; reporting to the management.
- Incidents root analyses and predictive maintenance actions.
Arcelor Liège – Services and Processes manager - Quality assurance driver – Team manager
- Description in documents and flowcharts of new processes according to the guidelines given by the top management and the standards, to harmonize work processes throughout projects. Implementation and follow-up (definition of KPIs, measurements, corrective actions and improvements proposals). Coaching of project leaders.
- Definition and implementation of a new maintenance organization (separation of projects and maintenance): definition of processes with the management and the operational teams, realization, process description (documentation); change management.
- Leader of a group thinking about documentation handling and tools
- Quality assurance audits (in order to define and improve the maturity level of the organization).
- Management of four supply chain IT teams: work organization and work processes description (project development, incident management, maintenance and support of several IT applications: expedition SW, supply chain management, …), skills matrix and training plan, backup, contact with professional unions… Definition of SLAs and follow-up.
Arcelor Liège – Project portfolio manager and customers relationship
- Contact with customers, management of deadlines, budgets…on the complete project portfolio.
- Contracts management; definition of SLAs and follow-up.
Arcelor Liège – Project manager
- For a new expedition system: project management (planning, team work organization…)
- Contact with end-users and different stakeholders; follow-up of realizations.
- Training and end-user coaching and support. Technical and end-users documents writing.
Consultant and Business Analyst Brussels, Belgium
July 1998 --- August 2002
- product management and customer contact;
- implementation and installation of a banking software (control of communication between payment terminal and bank). Training of end-users, technical writing.
Finance and insurance:
- design and implementation of Business Intelligence and reporting solutions;
- conciliation between opposite points of views and positions;
- complex problem solving.
- member of the maintenance team for rating applications in a telecom company.
AdaptabilityAnalytical thinkingCollaborationEfficiencyOptimismProblem solvingService orientedFlexibility
Cinvil Engineer in Applied mathematics from Université Catholique de Louvain in 1998