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Sr. Quality System Specialist
Quality and Validation Engineer at Medtronic supporting medical-device design controls, verification testing, and regulatory readiness.
United StatesSr. Quality System Specialist at Medtronic
Executed medical device design and development activities in accordance with Design Controls, ISO 13485, and FDA requirements. Developed mechanical components using SolidWorks/3D CAD and led design verification, FEA, and risk management activities.
Solidworks3D CADGD&TFEAFMEAISO 14971Design ControlDesign VerificationRisk ManagementMechanical Tolerance AnalysisStatistical AnalysisInjection MoldingRegulatory Submissions
Performed testing of raw materials, components, prototypes, and finished medical devices per specifications and GMP. Supported Design History File, design verification, risk management, and regulatory documentation.
21 CFR 820ISO 13485ISO 11608ISO 14971Design ControlDesign VerificationDHFRisk ManagementData AnalysisContinuous Improvement
Executed Computerized System Validation (CSV) activities for GxP applications in pharmaceutical manufacturing. Managed equipment qualification, calibration, and validation documentation.
CSVGxPIQ OQ PQ ValidationValidation ProtocolsRequirement TraceabilityData IntegrityCalibrationPreventive MaintenanceVendor ManagementAudit Support
Executed Computer System Validation (CSV) activities for GxP-regulated applications. Created and reviewed validation deliverables including URS, protocols, and traceability matrices.
CSVGxPURSIQ OQ PQ ValidationRequirement TraceabilityValidation Summary ReportsGMPData IntegrityDocument Control
Executed Quality Assurance activities supporting API manufacturing operations, ensuring GMP compliance. Investigated deviations and non-conformances, performing root-cause analysis.
GMPSOP流程设计Batch Record ReviewDeviations and InvestigationsRoot Cause AnalysisCAPAContinuous ImprovementLaboratory TestingCalibration
Master's degree in Information Technology Management from Indiana Wesleyan University, completed in 2023.
Master's degree in Information Technology Management from Indiana Wesleyan University, completed in 2023.
Bachelor's degree in Mechanical Engineering from Ramachandra College of Engineering, completed in 2016.
Bachelor's degree in Mechanical Engineering from Ramachandra College of Engineering, completed in 2016.
Profile sourced from Himalayas.