“Tony is great person to work with. He is very knowledgeable of engineering change management processes as well as QA and supply chain in the aircraft industry. Tony has also written several procedure manuals that spec out organized work flows in all departments. He is a valuable asset to any company, and I am proud to have worked with him. Angela Anderson Pega BPM/CRM Automation Developer BBA Aviation, plc”
Tony Williams
Santa Clarita, California, United States
1K followers
500 connections
About
• Self-motivated and organized Document Control/Quality leader with over 8 years of…
Activity
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Energy is everything! Call today to start healing 661-993-8465
Energy is everything! Call today to start healing 661-993-8465
Liked by Tony Williams
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Quality is fundamental to life science manufacturing, and integrating quality and manufacturing functions is vital for producing safe and effective…
Quality is fundamental to life science manufacturing, and integrating quality and manufacturing functions is vital for producing safe and effective…
Liked by Tony Williams
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I'm very excited that we've rolled out our new Fun Pass membership program nationwide -- a bespoke paid, tiered loyalty program that is truly a…
I'm very excited that we've rolled out our new Fun Pass membership program nationwide -- a bespoke paid, tiered loyalty program that is truly a…
Liked by Tony Williams
Experience
Education
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University of Phoenix
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Licenses & Certifications
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Master Certification Program
MasterControl
Issued
Courses
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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
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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.
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Service Now
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Created a ticketing system for several departments. Designed work flows and departments requirements
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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
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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
Recommendations received
35 people have recommended Tony
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