Pragya Jai Kumar
Quality Manager @Siemens Healthineers
San Jose, CA, US
EMAILS
k••••••••@siemens-healthineers.com
MOBILE NUMBERS
+14•••••••35
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WORK HISTORY
Aug 2022 — Present
Quality Manager @Siemens Healthineers
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Managing a global organization in alignment with FDA, EU MDR and other applicable regulations and standards for Post-Market Surveillance. • Leading Ultrasound Complaint Handling Unit, responsible for complaint investigations, Adverse Event reporting and complaint trend analysis. • Managing device Post-Market Surveillance data • Provide input to QMS aspects such as HRE evaluations, recalls, CAPAs, product risk management.
SKILLS
TeamworkQuality System ComplianceImage ProcessingHorizontal AnalysisCt ImagingComplaint InvestigationsClearquestCapaWork EthicBiomaterialsTrackwiseCross-Functional Team LeadershipImagejBiomedical EngineeringLabviewTissue EngineeringCollaborative Problem SolvingMatlabClinical CardiologyScanning Electron MicroscopyStatisticsFdaC++InitiationNmrMedical DevicesNmr SpectroscopyBiomechanicsSolidworksAlgorithmsSpectroscopySignal ProcessingImage AnalysisSimulinkCell CultureFluorescence Microscopy
ABOUT PRAGYA JAI KUMAR
Interests: Medical Device Regulations, Complaint Handling, Post-market…
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