Experience

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  Ge healthcare

  Jul 2011 - Feb 2024

  1. Responsible for driving & owning overall QMS compliance for diagnostic imaging device business at site. 2. Development and deployment of procedures; monitoring of production & process controls for the diagnostic imaging device business at site.3. Execution of transfer programs (design, manufacturing, supplier); 4. Driving improvement opportunities via product, process and quality system Corrective And Preventive Action (CAPA) activities; 5. Driving the training metrics.6. Driving lean initiatives leveraging six sigma tools. Proponent of DMAIC methodology.7. Trained for Risk management activities recording & documentation and solely responsible for the management of Risk Management File for the products handled - Pfmea8. Preparation and conduction of Total quality and Management Reviews9.Enable sustenance & improvements of established Quality System for increased effectivenessat siteAudit:1. SPOC for MDSAP audit readiness. (Medical Device Single Audit Program for US FDA, Health Canada, and Australia, Brazil and Japan's Administration). Hands-on with 6 MDSAP audits as SME. 2. Participated in site audits as SME: IMDR by CDSCO India, UL, FDA, Intertek, ANVISA Show less Project Lead:1.Execution of MRI System product transfer to Bangalore site, ensuring all QMS and Manufacturing activities are compliant for smooth transfer2.Lead the transfer of MR Magnet by providing hands on training and technical guidance on product educated from International assignment at CHINA.3.Own & Lead the implementation of digital transformation projects at site -UDI, Tableau, electronic device history record & electronic Defect management system4.Develop, Verification & Validation of all manufacturing process for successful transfer of new products - MR Cabinet, Ultrasound probes , MR Magnet.5.Establish Manufacturing Process and BOM structure by reviewing Engineering drawings & specifications6.Responsible for ensuring design outputs release & milestone deliverables7. Create and Own Project plans & Post release Project Plans w.r.t seamless transition for production Show less Process Engineering: 1. Establish & Maintain the Process of building and testing Products. 2. Responsible for monitoring and measurement of processes - improving First Pass Yield and DPU3. Driving culture of process improvements and kaizen among production associates. Driven significant number of Kaizens and Poke-yoke. 4. Driving brilliant factory initiatives and simplification projects through lean six sigma concepts;5.Reviewal & updation of SOP’s/Procedures/DHR based on Design Changes/Process Improvements/feedback from Customers6.Develop, Verification & validation of all poka-yoke Jigs & fixtures used for manufacturingprocess.7. Ensure Preparedness for audits by FDA Audits, global Quality council (GQC) audits, GMED audits, MDSAP, Audits by Certification/Test Labs, Quarterly internal quality audits.Product Quality:1. Driving product quality for MR subsystems ( RF coils and Gradient amplifiers +power supplies)2. Root-cause analysis for manufacturing defects for products owned. 15+ product catalogues of RF coils and gradient amplifiers & power supplies part of MRI system.3. Owning materials review board and driving cost of quality culture with suppliers. 4. Working with suppliers across continents to reduce part defects and improve product quality. Audited multiple supplier and collaborated for multiple action implementations. 5.Ensure Closure of non-conformities using RCA & CAPA process.Change Management:1. Design change implementation; Initiation of design change for manufacturing related activities.2.Monitor and ensure timely Execution of Engineering Changes Order (ECO) with constant interaction with the cross functional teamsNew Product Introduction:1. Line readiness; Establishing Z-score.2. Driving process excellence. 3. Product transfers and release to productionDigital Transformation:1. Hands-on experience on MES Application like eDHR. Product route creation, to back-end testing, to validation and implementation. Show less

  • Quality Assurance Lead

    Nov 2019 - Feb 2024

  • Senior Manufacturing Engineer

    Jan 2016 - Oct 2019

  • Manufacturing Engineer

    Jul 2011 - Dec 2015
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  Cisco

  Aug 2022 - now

  Product lifecycle project manager