Chargé d'Etudes Validation de Process F/H
Core
Ensure qualified and validated state of production equipment and processes in a medical device manufacturing facility, ensuring compliance with regulations and standards.
Role type
Process Validation Engineer (Quality Assurance)
Builds
Production equipment and manufacturing processes for medical devices
Domain
Medical device manufacturing / Quality Assurance
Required skills
Process validation (QI, QO, QP), Risk analysis (FMEA), Technical test execution, Regulatory knowledge (Medical devices/Pharma), Corrective action management, Documentation writing
Preferred skills
Project management, Team collaboration
Technologies
QMS software, Validation protocols, Risk assessment tools
Responsibilities
Propose and implement qualification/validation activities for equipment and processes, Draft validation dossiers, protocols, and functional/criticality/risk analyses, Coordinate and execute technical tests, Ensure periodic revalidation of production equipment, Analyze non-conformities and follow up corrective actions, Coordinate stakeholders involved in qualification activities