Olivier BAIL

En résumé

Entreprises

• MEDEX by Guerbet - Responsable Qualité Produits/Fournisseurs

  2011 - maintenant Medex by Guerbet est une entreprise médicale spécialisée dans la fabrication d'injecteurs et de dispositifs médicaux associés pour l'injection de produits de contraste dans le cadre de l'imagerie médicale.
  
  Responsable Qualité opérationnelle (réclamations, production)– Qualité Projet – Qualité fournisseurs
  
  Gestion de la politique d’assurance qualité Projet
  Support Qualité des équipes projet
  Définition du Design control (Design Input Specifications/Design verification/Design validation,etc..)
  Mise en place des stratégies de validation Process (QI/QO/QP)
  Gestion des modifications produit/process (Change control)
  Organisation et définition des spécifications R&D, achats et clients
  Gestion de la politique d’assurance qualité fournisseurs (Rédaction et suivi des contrats d’assurance qualité des fournisseurs)
  Responsable de la qualité en production (gestion des contrôles réception, en production)
  Libération des injecteurs ou des lots de consommables
  Responsable Métrologie
  Responsable du management des risques Produit/process (AMDEC)
  Analyse des réclamations
  Audits internes
  Audits Fournisseurs et suivi des plans d’action
  
  Réalisation :
  Mise en place de la procédure de développement produit et formation associée
  Mise en place de la procédure de maîtrise des modifications « change control » et formation associée
  Mise en place de la procédure de qualification process (injection plastique, assemblage, conditionnement)
  Déploiement de la fonction métrologie
  Refonte des cahiers des charges produit
  Rationalisation des contrats fournisseur
  

• Becton Dickinson - WWW Project Quality Engineer

  Le Pont de Claix 2007 - 2011 BD, a leading global medical technology company that makes and sells medical devices, instrumented systems and reagents, is dedicated to improving people’s health throughout the world. BD is focused on improving drug therapy, enhancing the quality and speed of diagnosing infectious diseases, and advancing research and discovery of new drugs and vaccines. The Company’s capabilities are instrumental in combating many of the world’s most pressing diseases. Founded in 1897 and headquartered in Franklin Lakes, New Jersey, BD employs more than 25,000 people in approximately 50 countries throughout the world. The Company serves healthcare institutions, life science researchers, clinical laboratories, industry and the general public.
  
  Description
  Position is responsible for assuring quality standards are consistent with Corporate and
  Division Policies, Government Regulations, International Standards and Standards of the
  Medical Device Industry. I will cross-functionally support all quality activities
  for several product lines, manufacturing sites, raw material and OEM Suppliers. The position
  requires the ability to handle multiple projects and tasks utilizing a high level of written and
  oral communication skills. Additionally, I must possess the ability to: initiate
  projects, become thoroughly knowledgeable with all aspects of the projects and assume responsibility through successful completion of the project.
  
  Responsibilities include the following:
  - Function as a Project Team Member to support Projects. Work closely with other functions within the organization (Manufacturing, R&D, Quality, Engineering, Procurement, Marketing)
  - Assess current operations for quality and compliance.
  - Develope and implement strategic quality plans, master validation plans, validation protocols, inspection plans and quality/regulatory compliance operating procedures to meet FDA (Food and Drug Administration) and ISO (International Organization of standardization) requirements.
  - Review validation protocols for effectiveness and compliance to Division Guidelines.
  - Develop and implement quality improvement programs at Division, Manufacturing sites and raw material/OEM Suppliers.
  - Assist with Complaint Failure Investigations.
  -Develop, document and/or maintain design history files.
  
  Qualifications
  I independently interface with numerous functions, manufacturing plants, and suppliers. Therefore, the position requires the ability to balance priorities and commitments. The following qualifications are necessary:
  - Thorough knowledge of quality system regulations/requirements (i.e. ISO-International Organization for Standardization, FDA-Food and Drug Administration, GLP / GMP-Good Lab /Manufacturing Practices, QSR-Quality System Regulation, EPA- Environmental Protection Agency).
  - Ability to perform multiple tasks and effectively manage conflict.
  - Ability to work in teams to obtain results, self motivate/direct
  - Ability to organize and supervise activities with minimal supervision.
  - Knowledge of manufacturing processes and relevant statistical techniques (Six Sigma, Statistical Process Control (SPC). Intermediate to extensive proficiency in Microsoft Office and statistical programs (i.e.MiniTab, SAS).
  - Understanding of continuous improvement methodologies including lean, six sigma, and validation.
  - BS degree in Engineering.
  - Excellent written and oral communication skills
  - Excellent problem solving and analytical skills
  - Ability to thoroughly evaluate, clearly understand and communicate all aspects of assigned project.
  - Knowledge of Medical Device or pharmaceutical regulatory standards
  - SAP experience is a plus.
  - Deal with wide variety of cross-functional quality related functions.
  - Ability to lead efforts aimed at the identification of problematic situations, the reporting of issues, and the development of resolutions.

• Mecaplast - Responsable assurance qualité développement

  Clamart 2004 - 2007 Interface qualite avec clientèle, anticipation des risques projet/produit/process (AMDEC), suivi des plans d’actions, planification des tâches Qualité, création des dossiers d’assurance Qualité, présentation des échantillons initiaux, analyses des rapports métrologie et laboratoire, établissement des cahiers des charges de composants extérieurs, formation du personnel de production aux nouveaux produits, suivi Qualité des fournisseurs, audit processus (interne et fournisseurs), …
  
  Projets :
  *Client Faurecia : Coques de siège B58 (remplaçante Citroën Picasso) avec concept de tablette aviation et intégration d’écran multimédia
  déployable, poignée d’articulation de dossier
  *Client PSA: Projet T7 (remplaçante Peugeot 307):Pare boue, baguettes de porte (avec et sans peinture), fonction grille d'auvent
  *Client Volvo Trucks/Renault Trucks :Grilles de calandre, coins ronds, emblème, pièces sous capot

• Visteon - Ingénieur qualité développement

  PARIS LA DEFENSE 2003 - 2003 Stage de fin d'étude
  Projet D2 (peugeot 407)
  Panneaux de porte

Formations

• Institut Textile Et Chimique De Lyon ITECH

  Ecully 2000 - 2003 Matériaux plastiques

Réseau

• Alexia GIOVANNETTI

• Arnaud MAIROT

• Austin Kellas INTERNATIONAL

• Catherine FELIX-FAURE

• Christophe ROUVIERE

• Gerard PUERTAS

• Huwer LAURENT

• Marc FLIPPE

• Michel IMBERT