Rahul Dhamodharan

About Rahul Dhamodharan

QARA Specialist | Post-Market Surveillance | EU MDR | ISO 13485 | Risk Management | Class…

Experience

1. Lead Design Quality Engineer

   美敦力

   Sep 2023 — Present · Hyderabad, IN

   Post market quality activity including risk evaluations, product trending and signal evaluation, complaint investigations, and surveillance reporting for the Cardiovascular (CVG), Structural Heart & Aorta (SHA), Diabetes and Neurosciences operating unit. Investigation of complaints for products in accordance with applicable internal procedures and work instructions and external requirements.Responsibilities Provide quality engineering support and process ownership for global post market surveillanceprocesses Support the cross-functional teams specifically focusing in the areas of product investigations, complaint investigations, escalated issue investigations, and PMS plans and reports Responsible for global PMS & Risk Management document submissions and requirements related to Class I,II and medical devices worldwide Define and maintain statistical thresholds for complaint monitoring and execute post market trending process Collaborate with cross-site Post Market Quality, Regulatory Affairs, and Engineering to support and author pre- and post-market product risk assessments Author, review and validate PMS technical documentation and PMS documentation submissions for new devices and device change notifications as required Prioritize and lead/participate in the assessment and solution development for identified issues and complexity including CAPAs, non-conformances, and quality assurance action plans Responsible for mentoring, coaching, and developing team membersExpertise: PMSR/PSUR remediation, Hazard Analysis, Trend Reporting, CAPA, RMR, PMSP

Education

• PSG Sarvajana HSS

  Year 12, Maths, Physics, Chemistry, Biology

  2004 — 2006

• Singhania University

  Master of Technology - MTech, Environmental/Environmental Health Engineering

• Flinders University

  Postgraduate Degree, Medical Biotechnology

  2010 — 2012

• Sri Ramakrishna MHSS

  Year 10

  1993 — 2004

• HimalayanUniversity

  Master of Science - MS, Clinical Laboratory Science/Medical Technology/Technologist

  2017 — 2019

• HimalayanUniversity

  Master of Science - MS, Medical Microbiology and Bacteriology

  2015 — 2017

• PSG College of Arts & Science

  Bachelor of Science (BS), Biotechnology

  2006 — 2009

Skills

• Real-Time Pcr
• Gc-Ms
• Assay Development
• Glp
• Teaching
• Microscopy
• Higher Education
• Dgge
• Lecturing
• University Teaching
• Dna Extraction
• Good Laboratory Practice (Glp)
• Hplc-Ms
• Environmental Microbiology
• Sds-Page
• Immunoassays
• Corrective and Preventive Action (Capa)
• Statistics
• Distance Learning
• Research
• Capa
• Hplc
• Tlc
• Elisa
• Molecular Biology
• Pharmaceutical Biotechnology
• High-Performance Liquid Chromatography (Hplc)
• Gmp
• Biotechnology
• Gas Chromatography
• Standard Operating Procedure (Sop)
• Ftir
• Immunohistochemistry
• Qpcr
• Environmental Biotechnology
• Hplc-Dad
• Science
• Sop
• Microbiology