Owner And Principal Consultant - New Product Development And Quality Consulting
Axiom Engineering Group Llc
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Nicholas Gonzalez, Cqe Cqa Email & Phone Number
Owner and Principal Consultant - New Product Development and Quality Consulting
at
Axiom Engineering Group LLC
1 work email found
@medtronic.com
LinkedIn matched
✓ Verified Jun 2026
4 data sources
Profile completeness 100%
Current company
Role
Owner and Principal Consultant - New Product Development and Quality Consulting
Location
Miami-Fort Lauderdale Area, United States, United States
Company size
Who is Nicholas Gonzalez, Cqe Cqa? Overview
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Quick answer
Nicholas Gonzalez, Cqe Cqa is listed as Owner and Principal Consultant - New Product Development and Quality Consulting at Axiom Engineering Group LLC, a company with 10 employees, based in Miami-Fort Lauderdale Area, United States, United States. AeroLeads shows a work email signal at medtronic.com and a matched LinkedIn profile for Nicholas Gonzalez, Cqe Cqa.
Nicholas Gonzalez, Cqe Cqa previously worked as Program Management & Principal Consultant (CAPA, Process Engineering, & Supplier Quality) at Medtronic and Principal Consultant / R&D Consultant at Medtronic. Nicholas Gonzalez, Cqe Cqa holds Core : Credential Of Readiness" from Harvard Business School.
Company email context
Email format at Axiom Engineering Group LLC
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*@medtronic.com
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AeroLeads found 1 current-domain work email signal for Nicholas Gonzalez, Cqe Cqa. Compare company email patterns before reaching out.
Profile bio
About Nicholas Gonzalez, Cqe Cqa
Nicholas Gonzalez, Cqe Cqa is a Owner and Principal Consultant - New Product Development and Quality Consulting at Axiom Engineering Group LLC. He possess expertise in validation, v&v, medical devices, six sigma, quality assurance and 32 more skills. Colleagues describe him as "I had a pleasure working with Nicholas at Beckman Coulter. Nicholas is one of the best quality leaders I had ever worked with. He is extremely knowledgeable and easy to work with. He is a true problem solver and a team player. Nicholas would be a great addition to any organization." and "Nick was my project manager for an assignment that covered several topics including risk management, test method validation, and regulatory compliance. He did an excellent job establishing goals and timelines, focusing the project, and providing technical support when we needed it. His work ethic is commendable, as he accomplished this while also managing his own individual tasks. He is truly an adept engineer, one I would gladly report to or work alongside in the future."
Listed skills include Validation, V&V, Medical Devices, Six Sigma, and 33 others.
Current workplace
Nicholas Gonzalez, Cqe Cqa's current company
Company context helps verify the profile and gives searchers a useful next step.
Axiom Engineering Group Llc
9 roles
Nicholas Gonzalez, Cqe Cqa work experience
A career timeline built from the work history available for this profile.
Program Management & Principal Consultant (Capa, Process Engineering, & Supplier Quality)
CurrentProgram manager and CAPA owner of large scale design control, quality, and regulatory projects to include a post acquisition design control remediation and 5 CM/OEM supplier controls 483 remediation projects.
Oct 2016 - Present
Principal Consultant / R&D Consultant
Lead the effort with senior leadership to revise site level Design Control procedures and processes up to current industry practices as well as FDA and EU MDR regulatory requirements. Provided oversite and expertise in the remediation of the design documentation of multiple ENT product lines to bring into FDA design control and EU MDR compliance as part of.
Aug 2020 - Jul 2022
Oct 2016 - Present
Owner / Principal Consultant - New Product Development / Quality Consulting
Current
Axiom Engineering Group Llc
Axiom Engineering Group has had the privilege of consulting at many different and dynamic medical device companies. We are a Quality Engineering Company focusing on program management, new product development, design controls, supplier controls, process validation, design verification and validation, test method validation, and risk management. Please feel.
Mar 2010 - Present
New Product Development Core Team Lead - Staff Quality Engineering
Program Manager / CAPA Owner for an FDA 483 remediation effort. New Product Development Quality Core team lead for diagnostic design change and new product development projects.
Nov 2013 - Oct 2016
Program Manager- Quality
In my role as Project Manager and Senior Quality Engineer I worked on and led large scale remediation efforts at some of the largest medical device companies across the continental US.
Mar 2010 - Sep 2013
Project Engineer
Lead designer for electrical distribution projects such as the design and relocation of electrical service from overhead poles to underground duct banks for Palm Island, FL and the city of Golden Beach, FL. One other notable project was my design of the 4000 foot duct bank connecting Lawrence substation with the new Florida Marlins baseball stadium.
Jun 2007 - Mar 2010
Quality Engineer
Worked as a QE consultant for clients such as Boston Scientific. Created and ran Installation, Operational, Process, and Product Qualifications as well as Test Method Validations for a company wide quality improvement effort.
May 2006 - Jun 2007
Team & coworkers
Colleagues at Axiom Engineering Group LLC
Other employees you can reach at medtronic.com. View company contacts for 10 employees →
KR
Kelvin Rosario
Colleague at Axiom Engineering Group LlcSanto Domingo, Distrito Nacional, Dominican Republic, Dominican Republic
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LX
Lon Xyn
Colleague at Axiom Engineering Group LlcFox Lake, Illinois, United States, United States
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DK
Dean Kolonich
Colleague at Axiom Engineering Group LlcCherry Hill, New Jersey, United States, United States
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FB
Frédéric Blanc
Colleague at Axiom Engineering Group LlcLausanne, Vaud, Switzerland, Switzerland
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BA
Becky Ahlers
Colleague at Axiom Engineering Group LlcSt Paul, Minnesota, United States, United States
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GB
Gabriela Berríos Negrón
Colleague at Axiom Engineering Group LlcPonce, Puerto Rico, Puerto Rico
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AT
Akbar Turgunbaev
Colleague at Axiom Engineering Group LlcUzbekistan, Uzbekistan
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GY
Gary Yang
Colleague at Axiom Engineering Group LlcMinneapolis, Minnesota, United States, United States
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SK
Suraj Kalbhile
Colleague at Axiom Engineering Group LlcChhatrapati Sambhajinagar, Maharashtra, India, India
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JB
J.J. Boyke
Colleague at Axiom Engineering Group LlcWaukesha, Wisconsin, United States, United States
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Kelvin Rosario
Colleague at Axiom Engineering Group LlcSanto Domingo, Distrito Nacional, Dominican Republic, Dominican Republic
View →
LX
Lon Xyn
Colleague at Axiom Engineering Group LlcFox Lake, Illinois, United States, United States
View →
DK
Dean Kolonich
Colleague at Axiom Engineering Group LlcCherry Hill, New Jersey, United States, United States
View →
FB
Frédéric Blanc
Colleague at Axiom Engineering Group LlcLausanne, Vaud, Switzerland, Switzerland
View →
BA
Becky Ahlers
Colleague at Axiom Engineering Group LlcSt Paul, Minnesota, United States, United States
View →
GB
Gabriela Berríos Negrón
Colleague at Axiom Engineering Group LlcPonce, Puerto Rico, Puerto Rico
View →
AT
Akbar Turgunbaev
Colleague at Axiom Engineering Group LlcUzbekistan, Uzbekistan
View →
GY
Gary Yang
Colleague at Axiom Engineering Group LlcMinneapolis, Minnesota, United States, United States
View →
SK
Suraj Kalbhile
Colleague at Axiom Engineering Group LlcChhatrapati Sambhajinagar, Maharashtra, India, India
View →
JB
J.J. Boyke
Colleague at Axiom Engineering Group LlcWaukesha, Wisconsin, United States, United States
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2 education records
Nicholas Gonzalez, Cqe Cqa education
Core : Credential Of Readiness"
Harvard Business School
Bachelor Of Science, Mechanical Engineering
University Of Miami
FAQ
Frequently asked questions about Nicholas Gonzalez, Cqe Cqa
Quick answers generated from the profile data available on this page.
What company does Nicholas Gonzalez, Cqe Cqa work for?
Nicholas Gonzalez, Cqe Cqa works for Axiom Engineering Group LLC.
What is Nicholas Gonzalez, Cqe Cqa's role at Axiom Engineering Group LLC?
Nicholas Gonzalez, Cqe Cqa is listed as Owner and Principal Consultant - New Product Development and Quality Consulting at Axiom Engineering Group LLC.
What is Nicholas Gonzalez, Cqe Cqa's email address?
AeroLeads has found 1 work email signal at @medtronic.com for Nicholas Gonzalez, Cqe Cqa at Axiom Engineering Group LLC.
Where is Nicholas Gonzalez, Cqe Cqa based?
Nicholas Gonzalez, Cqe Cqa is based in Miami-Fort Lauderdale Area, United States, United States while working with Axiom Engineering Group LLC.
What companies has Nicholas Gonzalez, Cqe Cqa worked for?
Nicholas Gonzalez, Cqe Cqa has worked for Axiom Engineering Group Llc, Medtronic, Mec Innovations, Beckman Coulter, and Goode Compliance International.
Who are Nicholas Gonzalez, Cqe Cqa's colleagues at Axiom Engineering Group LLC?
Nicholas Gonzalez, Cqe Cqa's colleagues at Axiom Engineering Group LLC include Kelvin Rosario, Lon Xyn, Dean Kolonich, Frédéric Blanc, and Becky Ahlers.
How can I contact Nicholas Gonzalez, Cqe Cqa?
You can use AeroLeads to view verified contact signals for Nicholas Gonzalez, Cqe Cqa at Axiom Engineering Group LLC, including work email, phone, and LinkedIn data when available.
What schools did Nicholas Gonzalez, Cqe Cqa attend?
Nicholas Gonzalez, Cqe Cqa holds Core : Credential Of Readiness" from Harvard Business School.
What skills is Nicholas Gonzalez, Cqe Cqa known for?
Nicholas Gonzalez, Cqe Cqa is listed with skills including Validation, V&V, Medical Devices, Six Sigma, Quality Assurance, Design Control, Iso 13485, and Fmea.
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