> Agence : FMC SMAD
> Date de publication :
> Type de contrat : CDI temps plein
> Ville (CP) : SAVIGNY 69210
> Région : Auvergne-Rhône-Alpes


In the In Center, Quality and Regulatory, Global Product Center Structure, the Design Quality Assurance Expert 'Concentrates' will be responsible to ensure the quality of Design Control Activities. 

  • Ensure that all design control deliverables comply with applicable regulatory requirements and desgin controls SOPs. 

  • Prepare together with Project Manager's the design and development documentation for project and for design control activities

  • Support Product Center/Project Manager to get part of DHF needed to Medical Device Compliance and Regulatory Affairs to complete Technical Dossier / Registration Dossier.
  • Provide Training on design & development relevant quality requirements
  • Provide input to design development and design changes and take accountability for quality compliance as a member of the cross-functional project team representating Product Center for Design Quality Part.
- Preparation / Review and approvals of applicable design control documentation
- Design Review, Phase Exit Review and Milestone approval
- Preparation of applicable document and sample review of design control document during project execution
  • Review and approve all product development and design change project in compliance with Fresenius Quality Management System / SOP requirements by :
  • Quality Approver for Design and Development related NC/CAPA

Additional tasks due to main duties :
Audit support of design and development sessions
Providing management quality review inputs for Design and development
MD Compliance Expert : support of Product Center in writing MDR Technical documentaion and related documentation.


  • Degree in a technical or scientifc field, such as medical technology
  • Knowledge of the requirements for the quality management system of medical devices (e.g. MDD/MDR and 21 CFR 820, Order No.7 and Oder No.64 for Chinese regulation) 
  • Professional experience in research and development, regulatory affairs or quality management for medical devices or phamaceuticals.
  • Experience with the requirements (21 CFR 820) and monitoring inspections by the American Food and Drug Administration (FDA) is desirable. 
  • English good level skilss 
  • Standard applications (especially MS Office), PDM System, QMS-Software