Mahesh Mandya
Lead Engineer (Design Control, Quality and Risk Management) @Caliber Assurance Services
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WORK HISTORY
Lead Engineer (Design Control, Quality and Risk Management) @Caliber Assurance Services
Working with Philips Healthcare - HIC MR Coils, MIDC-Chakan, Pune, Maharashtra. Medical Device: MR Coils(Magnetic Resonance) Manufacturer/OEM.
EDUCATION
PES Pre University college, Mandya-571401
Pre University 11th Standard, PCMB: Science
Visvesvaraya Technological University
Bachelor of Engineering - BE, Mechanical Engineering
National Children High School, Mandya-571401
10th Standard
PES Pre University college, Mandya-571401
Pre University 12th Standard, PCMB: Science
ABOUT MAHESH MANDYA
Total Experience: 8 Years of Experience in Medical devices | Philips Healthcare | Ex-GE HealthcareMedical Devices: X-ray tubes technology & MRI Coils.Hands on Experience. Medical Device QMS: ISO-13485/ FDA 21CFR 820 / ISO-14971-Risk Managements. MD Products : MR Coils (Magnetic Resonance Imaging) & X-Ray tubes technology. Design Controls, Design Quality & Assurance, DHF Remediation (Design History File), Product Gap Assessments, Risk Analysis & Control measures, dFMEA, Traceability, Verification Plan, Protocols, Reports. Product & Process Quality, Six-Sigma DMIAC, pFMEA, process flows/Audits, Non-Conformance, Product autopsy Investigations & failure analysis, CAPA & Actions plans, Root cause analysis & Problem Solving skills, Lean Manufacturing, Product house & People management etc. Engineering & Manufacturing Change management: ECR/ECN\'s, Management Review Boards/ ECRB/ DCRB/ QMRB, Global reviews, Windchill etc.
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