Karima Neffati

Review quality system ,SOP,records keeping ,manufacturing process

perform mock inspection

training team on what to inspect during inspection

Manage audit documentation ,evidence collection and compliance tracking

Lead the review and update of Process AMDEC/FMEA

Manage change requests and assess their impact on quality, regulatory compliance, and manufacturing processes

Driveand maintainthequalitypolicyacrosstheorganization Perfom human factoractivities. Drive Riskmanagementfilesactivities. Manageinternal and externalAudit. Reviewand approve characterization reports,verification andvalidation protocolsand reports,and associated experimental datatoensure compliancewith applicable proceduresandstandards. Defineand monitorqualityperformanceindicators(KPIs) lead correctiveand preventiveaction plans(CAPA). Manage non-conformitiesauditoutputs . Monotoring ofregulatorychangeand implementrequired impact. Build and maintain robustdesign historyfile. Reviewand approve design changes,assesstheimpactofthesechangeson Design HistoryFiles(DHFs) and Device Master Records(DMRs). Workwith cross-functionalteamstoensurethateveryonealignswith quality objectives. Ensure properprocessesarefollowed during design,development,and production .

Gatherand analyzestakeholderrequirements Definefunctional and technicalspecifications Manage requirement traceability Verifyandvalidatesystem requirements Ensurecompliancewithstandardsand regulations Coordinatewith design,testing,and projectteams Identifytechnical and operational risks Perform riskassessmentsand impactanalysis Develop mitigation and contingencyplans