Tony Williams

Tony Williams

Santa Clarita, California, United States
1K followers 500 connections

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University of Phoenix

About

• Self-motivated and organized Document Control/Quality leader with over 8 years of…

Activity

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Experience

  • NeuroTrauma Sciences, LLC Graphic

    NeuroTrauma Sciences, LLC

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    Remote

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    Greater Los Angeles Area

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    Greater Los Angeles Area

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    Venice beach CA

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    Northridge,CA

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    Northridge, CA

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    Studio City, CA

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    Northridge, CA

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    West Hollywood, CA

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    Burbank, CA

Education

  • University of Phoenix

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Licenses & Certifications

  • Master Certification Program

    MasterControl

    Issued

Courses

  • CAP-Change Acceleration Process

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  • Emotional intelligence

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  • ISO 13485

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  • Visualization data

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Projects

  • Unique Device Identification Deployment

    - Present

    he UDI initiative is an FDA requirement for tracking medical device information from medical device companies. This initiative required Medtronic corporate to create a strict process for all business units to follow, allowing management of GTINs/UPNs from creation to release. With every unique business requirement, a universal process had to be created and accepted.
    My role was to review corporate requirements and adjust to the business needs. Due to these new requirements, I lead the…

    he UDI initiative is an FDA requirement for tracking medical device information from medical device companies. This initiative required Medtronic corporate to create a strict process for all business units to follow, allowing management of GTINs/UPNs from creation to release. With every unique business requirement, a universal process had to be created and accepted.
    My role was to review corporate requirements and adjust to the business needs. Due to these new requirements, I lead the process improvement of the Northridge GTIN approval process by providing requirements and design specifications for the creation of a new web form. Once the process was accepted, the business unit needed SOP/DOP creation to follow these guidelines. I also lead the Regulatory and Document Control departments on SOP/DOP creation and updates, which also requirement training that I lead.

    See project

  • Service Now

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    Created a ticketing system for several departments. Designed work flows and departments requirements

  • SharePoint (Document Control Library)

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    Design Document Control Library requirements
    -Migrated over 160K of documents into new system
    -Created roles and security
    -Administer to SharePoint
    -Trainer for new user

Honors & Awards

  • Global Regulatory Affairs Excellence Award

    Medtronic Global Regulatory Affairs

    The Global Regulatory Affairs Excellence Award recognizes extraordinary regulatory
    performance and a strong commitment to the respective business unit/regional goals and the
    Medtronic Mission. Regulatory Affairs excellence accelerates global introduction and adoption of
    new products and therapies by creating quality evidence that clearly demonstrates value to
    patients, clinicians, regulators, and payers.
    Across the company and geographies, employees dedicated to regulatory…

    The Global Regulatory Affairs Excellence Award recognizes extraordinary regulatory
    performance and a strong commitment to the respective business unit/regional goals and the
    Medtronic Mission. Regulatory Affairs excellence accelerates global introduction and adoption of
    new products and therapies by creating quality evidence that clearly demonstrates value to
    patients, clinicians, regulators, and payers.
    Across the company and geographies, employees dedicated to regulatory affairs excellence
    deserve to be recognized with our highest functional excellence award. This represents the
    chance to highlight individuals and teams from every business and geography. The clear intent
    of this award is to promote, recognize, and reward regulatory affairs excellence by Medtronic
    employees.
    The Global Regulatory Affairs Excellence Award program launched in 2014 as an annual
    program is sponsored by the Medtronic Regulatory Council and Pat Shrader, Vice President –
    Global Regulatory Affairs. Award recipients are honored and recognized during the Annual
    Global Regulatory Affairs Symposium as a celebration of the clear value regulatory affairs
    excellence brings to the individual businesses, Medtronic as a whole, and of most importance,
    our patients and health care providers

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