Claude ROUSSELLE

En résumé

Entreprises

• Immucor Gamma - RA/QA Manager

  Paris 2008 - 2013 RA/QA Manager for France/Benelux affiliates and involved in the recall process at International level. I have implemented the French quality system and harmonized it with the Belgian system.
  * Insure the maintenance of the quality system of French and Belgium affiliates :ISO 13485 and ISO 9001 ;
  * Implementation and follow-up of the Quality documentation (SOP, I, Forms...). ;
  * Manage the quality documentations via the share point portal software. ;
  * Implement the Quality Indicators and manage the CAPA by the trackwise software:
  * Processing of the complaints
  * Identify and trace the non-compliance ;
  * Investigation and implementation of the corrective and preventive actions. ;
  * Elaborate the documentary supports for the quality and regulatory trainings Prepare and participate at the European quality metric review. ;
  * Prepare and participate from the regulatory and quality inspections. ;
  * Internal audit at affiliate sites ( Italy, UK, Germany, Iberia) ;
  * Organization of the audit plans
  * Audit report ;
  * Action plan's Follow-up.
  * Recall management :
  * To verify the « inventory form »
  * Return control
  * Quantity reconciliation
  * Finalize and close the recall. ;
  * Deal with Competent Authority for incident and FSCA reports ;
  * To implement an archiving system regarding the quality documentation. ;
  * In charge of risk assessment for pMDR in Europe ( Trackwise software) for Europe ;
  * In charge of the follow-up of the regulatory standards applicable to CE marking for the International level ;
  * In charge of the preparation of the management review

• Immucor Gamma - RA/QA Manager

  Paris 2003 - 2008 RA/QA Manager for Benelux affiliate and involved in the recall process at International level
   *Insure the maintenance of the quality system of Belgium affiliates :ISO 13485:2000 and after 2003
   * Implementation and follow-up of the Quality documentation (SOP, I, Forms…).
   *Manage the quality documentations via the share point portal software.
   *Implement the Quality Indicators and manage the CAPA by the trackwise software:
   *Processing of the complaints,
   *Identify and trace the non-compliance ,
   *Investigation and implementation of the corrective and preventive actions.
   *Elaborate the documentary supports for the quality and regulatory trainings Prepare and participate to the European quality metric meetings.
   *Prepare and participate from the regulatory and quality inspections.
   Internal audit at affiliate sites
   Organization of the audit plans,
   Audit report,
   Action plan’s Follow-up.
   *Recall management :
   To verify the « inventory form »,
   Return control,
   Quantity reconciliation,
   Finalize and close the recall.
   Deal with Competent Authority for incident and FSCA reports
   *To implement an archiving system regarding the quality documentation.
   *In charge of the management review
   *In charge to elaborate, maintain and update the technical file of Belgian affiliate until end of 2007 ( End of manufacturing)
   *In charge of the Batch release approvals until end of 2007
   *Notification of new devices placed on the European market to the Belgian Competent Authorities
   *In charge to constitute and final approval of Device History files
   *Authorized Representative until December 2010. This activity has been transferred in January 2011 to the German site of Immucor
  

• MRC Company - Coating and Quality Manager

  1999 - 2002 * Implementations of the standard ISO 9002.I have put in place the quality system (redaction of SOP, forms and internal audit). This task has been finished when I have leaved the company. ;
  * Management of plastic, ceramic and cermet coating by plasma torch, laser, jet coat devices) ;
  * Management of 15 workers (Scheduling of tasks, trainings.....) ;
  * Approval of quality control results before release.

• ets Maurice Bodart - QA/ safety engineer

  1999 - 1999 Safety and Quality responsible. During these 6 months I have implemented a quality system ISO 9002 certified by TÜV and the Safety System call in Belgium BesAcc certificate 2000/8 _ Bodard Company (painting company)

• RMI Company - Coating and Quality Manager

  1996 - 1997 * Implementations of the standard ISO 9002.I have put in place the quality system (redaction of SOP, forms and internal audit). This task has been finished when I have leaved the company. ;
  * Management of plastic, ceramic and cermet coating by plasma torch, laser, jet coat devices) ;
  * Management of 15 workers (Scheduling of tasks, trainings.....) ;
  * Approval of quality control results before release

• Centre TSIRA - RD enginneer

  1990 - 1996 R&D engineer Design for different industrial items

• Solvay Company - Engineer

  1988 - 1989 * Improvement of the manufacturing of salt for the road during winter period (cost saving)

Formations

• ISIPH (Charleroi)

  Charleroi 1983 - 1988 Chemistry engineer
  
  chimie

• Haute Ecole Provinciale De Charleroi - Université Du Travail (Charleroi)

  Charleroi 1983 - 1988

Réseau

• Alexis LE JEAN

• Aurélie DIEU

• Jean LAMBERT

• Karine FRANCHET

• Laetitia PONCELET

• Laurent SAINT-ANDRE

• Marc FOULON

• Margot GROSS

• Nadia KEMMACH

• Stéphane OUDOT