Amit Mistry

Quality Assurance, Regulatory Affairs, and Document Control Manager at Ansh Labs
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Contact Information
us****@****om
(386) 825-5501
Location
Houston, Texas, United States, US
Languages
  • Gujarati -
  • French -
Skills

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Credentials

  • ISO 9001:2008 (with ISO 13485:2003 focus) Lead Auditor Certification
    ASQ
    Oct, 2014
    - Oct, 2024

Experience

  • Ansh Labs
    • United States
    • Biotechnology
    • 1 - 100 Employee
    • Quality Assurance, Regulatory Affairs, and Document Control Manager
      • Jul 2019 - Present

      Primary Role: Responsible for oversight of the company’s quality system, and management of QA, RA, and Doc Control functions, ensuring compliance to FDA and ISO (13485:2016) quality system regulations, and IVD directives. Main Responsibilities: Managing and executing all activities associated with complaint and CAPA processes, evaluating and resolving nonconformances (NCRs), conducting management review meetings, planning and leading internal audits, hosting external audits, coordinating and assembling regulatory submissions, performing manufacturing QC inspections, supporting international product registrations, ensuring control of documents, records, equipment and infrastructure. Show less

  • Indus Management Group
    • Operations Manager
      • Jun 2017 - Jun 2019

      Responsible for all aspects of property management (multi-family housing, 570 units), including operations management, project management, budget management, and financial analysis. Directly managed and supervised 15-20 team members. Responsible for all aspects of property management (multi-family housing, 570 units), including operations management, project management, budget management, and financial analysis. Directly managed and supervised 15-20 team members.

  • Cyberonics
    • Quality Engineer
      • Feb 2013 - Jun 2017

      Primary Role: Monitoring the implementation and execution of the overall Quality System for all stages of the implantable medical device system and components (including design, manufacturing, and post-market).Main Responsibilities: Conducting and providing oversight of investigations of nonconformances (NCRs) and CAPAs to identify root cause and corrective actions, supporting design and development of new products and product changes/enhancements, supporting validation and verification of systems and processes, monitoring of complaints and post-market trends for events requiring escalation to CAPA and leading and supporting such investigations and activities, coordinating and executing recall/field action activities, providing advanced technical support and training. Show less

    • Clinical Engineer
      • Oct 2010 - Feb 2013

      Primary Role: Providing clinical and technical support for implantable medical device (neurostimulator) and ancillary components to field-based employees and customers, including physicians and patients.Main Responsibilities: Providing support as needed for surgeries and troubleshooting issues, researching solutions to questions or problems concerning the device, identifying complaints for appropriate handling and reporting to FDA and other regulatory bodies, investigating product complaints, mentoring new team members. Show less

  • The University of Texas at Arlington
    • United States
    • Higher Education
    • 700 & Above Employee
    • Research Assistant
      • Dec 2008 - Aug 2009

      Performing research and development on a novel device, to gain knowledge of various aspects of cardiovascular disease and certain cancers.Main Responsibilities: Conducting experimental studies, recording and analyzing data, drafting and testing protocols, making improvements on device design and experimental setup, mentoring new team members, preparing experimental reports, preparing and presenting PowerPoint, podium, and poster presentations.Notable Achievements: Research chosen to be presented at 2009 BMES Annual Fall Meeting, validated research study by creating a 24-hour time lapse study, suggested and implemented ways of improving device design for simplified use and cost effectiveness. Show less

    • Graduate Teaching Assistant
      • Jun 2007 - Aug 2009

      Primary Role: Managing laboratory and instructing students on advanced laboratory topics and techniques in biology, such as: aseptic techniques, cell lines, cell culture, assays, DNA/RNA/protein analysis techniques, microscopy, staining, and fluorescence.Main Responsibilities: Supervising laboratory operations, assisting students with learning and understanding lab techniques, demonstrating proper lab safety/clean-up/maintenance, preparing lab materials, planning lab exercises/protocols, organizing class work, scheduling group meetings, delivering lectures, grading lab exercises/assignments. Show less

Education

  • The University of Texas at Arlington
    Master of Science (M.S.), Bioengineering and Biomedical Engineering
    2003 - 2009
  • The University of Texas at Arlington
    Bachelor of Science (B.S.), Biology, General
    2003 - 2009

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