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CAPSULE TECHNOLOGIE
- QA/RA Manager
Paris-13E-Arrondissement
2015 - maintenant
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CAPSULE TECHNOLOGIE
- Quality Assurance Engineer
Paris-13E-Arrondissement
2012 - 2014
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Diagnostica STAGO
- Quality Assurance Team Leader
Asnières-sur-Seine
2012 - 2012
Manage QA Team:
• Provide quality expertise and support to the QA team (SW, FW, HW and MECA) and site.
• Lead a team of Quality Assurance to excellence performance while maintaining a positive team environment.
• Ensure that team members are suitably trained to perform their assigned tasks on an ongoing basis.
• Oversee the day to day management of QA team, directing the workload of the QA team.
• Provide clear and open communication with the QA team and site.
• Ensure compliance to the Quality Management System is maintained and its effectiveness monitored.
• Formulate and manage the development and implementation of goals, objectives, policies, procedures, and systems pertaining to the QA.
• Perform trend analysis of QA related areas.
Project Quality Assurance:
• Responsible for ensuring all project (SW, FW, HW and MECA) design control documents such as requirements specifications, software development plans, configuration management documents, risk management documents and validation documents comply with Quality system Regulation: FDA 21 CFR 820.30, ISO 13485 and ISO 62304.
• Participate in activities to establish and maintain the Risk Management process, including application of ISO 14971. Contribute to hazard assessments and FMEAs.
• Responsible for Quality System vigilance in all software development activities
• Demonstrated use of Quality tools/methodologies including: Design Control, Risk Analysis (Hazard Analysis), Design FMEA, Requirements management and tracing, Statistical Analysis,
• Perform internal audits to ensure compliance with domestic procedure and international standards.
• Follow all Quality System Practices as defined per Companies practices, policies and Standard Operating Procedures to ensure that FDA, ISO and European Medical Device quality standards and regulations are met where applicable.
• Provide solutions to a wide range of difficult challenges. Work independently to determine and develop solutions that are imaginative, thorough, practicable, and consistent with organizational objectives.
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Diagnostica Stago
- Software Quality Team Leader
Asnières-sur-Seine
2011 - 2012
Manage QA Team:
• Provide quality expertise and support to the QA team (SW, FW, HW and MECA) and site.
• Lead a team of Quality Assurance to excellence performance while maintaining a positive team environment.
• Ensure that team members are suitably trained to perform their assigned tasks on an ongoing basis.
• Oversee the day to day management of QA team, directing the workload of the QA team.
• Provide clear and open communication with the QA team and site.
• Ensure compliance to the Quality Management System is maintained and its effectiveness monitored.
• Formulate and manage the development and implementation of goals, objectives, policies, procedures, and systems pertaining to the QA.
• Perform trend analysis of QA related areas.
Project Quality Assurance:
• Responsible for ensuring all project (SW, FW, HW and MECA) design control documents such as requirements specifications, software development plans, configuration management documents, risk management documents and validation documents comply with Quality system Regulation: FDA 21 CFR 820.30, ISO 13485 and ISO 62304.
• Participate in activities to establish and maintain the Risk Management process, including application of ISO 14971. Contribute to hazard assessments and FMEAs.
• Responsible for Quality System vigilance in all software development activities
• Demonstrated use of Quality tools/methodologies including: Design Control, Risk Analysis (Hazard Analysis), Design FMEA, Requirements management and tracing, Statistical Analysis,
• Perform internal audits to ensure compliance with domestic procedure and international standards.
• Follow all Quality System Practices as defined per Companies practices, policies and Standard Operating Procedures to ensure that FDA, ISO and European Medical Device quality standards and regulations are met where applicable.
• Provide solutions to a wide range of difficult challenges. Work independently to determine and develop solutions that are imaginative, thorough, practicable, and consistent with organizational objectives.
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DELPHI Electronic & Safety
- Ingénieur Qualité Logiciel & Système/ Sûreté de fonctionnement
2007 - 2011
- Assurer le suivi des développements logiciel internes et externes (Pologne et Inde).
- La mise en place de la démarche HIS & Automotive SPICE (ISO 15504) au BE,
- Assurer la conformité des activités systèmes et logicielles avec les standards logiciel et système,
- Assister le chef de projet logiciel dans l'application des dispositions du système qualité et d'assurer avec lui le respect des engagements client
- Sensibilisez les équipes à l’assurance de la qualité (Former l’équipe à la démarche qualité).
- Support aux équipes projets pour le déploiement des processus et de l'amélioration continue
- Mener des audits projet et de réaliser des contrôles de livraison.
- Participer à la résolution des problèmes d’application, et proposer des améliorations.
- Assurer la suivie de phasage des activités, définir les contraintes qualité, organiser des revues avec les sous-traitants et piloter les revues avec le client.
- Assurer le suivi du planning du projet (tenue des délais, réalisation des revues, des audits techniques...)
- Généraliser les méthodes de développement et les outils associés (gestion de configuration, gestion des exigences…).
- Effectuer un reporting régulier des activités auprès de Responsable Qualité et réaliser les analyses de risque en association avec les Responsables Projet.
- Participer à la Réalisation d'étude de sûreté de fonctionnement (Logiciel/Système) :
* Vérification de la documentation (relecture, traçabilité des exigences, ...)
* Participation à des relectures de code et de dossiers de conception
* Réalisation d'analyse préliminaire des risques (système & logiciel)
* Réalisation d'Arbre de défaillance
COMPETENCES
* Qualité logiciel :
Référentiels & normes :ISO/IEC 15504(ISO SPICE), CMM/CMMI, ISO 9126, ISO 9001 v 2000, ISO 25000, ISO TS 16949
* SDF :
Référentiels: Do 178B, Do 254, CEI 61508, ISO 26262, MISRA
Méthodes: AMDEC, AEEL, Arbres de défaillances, Fiabilité Prévisionnelle, SADT, Chaînes de Markov, Réseaux de Pétri, ARALIA.
* Gestion de configuration : PVCS Tracker & Version Manager, CM Synergy
* Gestion des exigences :Reqtify
