Aviktha Reddy

Manager, Quality Engineering - Disposables at Quest Medical, Inc.
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us****@****om
(386) 825-5501

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Credentials

  • Problem solving and Decision making
    Kepner-Tregoe
    Mar, 2020
    - Nov, 2024
  • Process validation and industry practice
    AAMI
    Apr, 2019
    - Nov, 2024
  • QMS lead auditor course ISO13485:2016
    Exemplar Global, Inc.
    Jan, 2019
    - Nov, 2024
  • Certified Quality Technician
    ASQ - World Headquarters
    May, 2018
    - Nov, 2024
  • Certified Quality Engineer (CQE)
    ASQ - World Headquarters
    Aug, 2019
    - Nov, 2024

Experience

    • United States
    • Medical Device
    • 100 - 200 Employee
    • Manager, Quality Engineering - Disposables
      • Feb 2022 - Present

      Mentor, develop and evaluate QE staff both internally and externally. Project management strategy to execute multiple projects across the organization. Utilizing Risk management principles to aspects of quality system. Manage CAPA, supplier quality for disposables. Develop and maintain RMF, SOP and QCP. Provide technical support to cross functional teams.

    • Quality engineer 11
      • Apr 2021 - Present

      Mentor quality engineering technicians, provide quality engineering support to NPD products, lead quality projects, supplier management, production quality support, validation and verification, continuous improvements.

    • Quality Engineer
      • Feb 2017 - Apr 2021

      Operations and New product development. Risk management, establish product inspection methods,supplier evaluation and supplier audit, lean manufacturing, validation and verification, quality audit, NCMR CAPA and trend analysis for finished goods medical device manufacturer.

    • United States
    • Medical Device
    • 1 - 100 Employee
    • Quality Engineer
      • 2016 - 2017

      Pre -market product quality assistance, assisted in verification and validation activities including minitab, problem solving and testing. Utilize word processing, spreadsheet review DOE data as required. Perform quality system updates to procedures per FDA Quality System Regulation such as MDD, ISO 9001,ISO 13485 and ISO 14971, risk management files and Design History Files for large multinational class 111 medical device manufacturer. Pre -market product quality assistance, assisted in verification and validation activities including minitab, problem solving and testing. Utilize word processing, spreadsheet review DOE data as required. Perform quality system updates to procedures per FDA Quality System Regulation such as MDD, ISO 9001,ISO 13485 and ISO 14971, risk management files and Design History Files for large multinational class 111 medical device manufacturer.

    • United States
    • Research Services
    • 1 - 100 Employee
    • Biomechanical Engineering Intern
      • 2016 - 2016

      Biomechanics of human body, simulation and analysis of muscle moment and force involved in human activities Biomechanics of human body, simulation and analysis of muscle moment and force involved in human activities

Education

  • Trine University
    Master of Business Administration - MBA
    2019 - 2021
  • Texas A&M University-Kingsville
    Master's degree, Mechanical Engineering
    2013 - 2015
  • Vemana Institute of Technology, BANGALORE
    Bachelor's degree, Mechanical Engineering
    2009 - 2013

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