DESIGN QUALITY ASSURANCE EXPERT H/F

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

Missions

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. 

MISSIONS :
  • 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.

Profil

  • 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

Autres