Nicholas Gonzalez, Cqe Cqa

Nicholas Gonzalez, Cqe Cqa Email and Phone Number

Owner and Principal Consultant - New Product Development and Quality Consulting @ Axiom Engineering Group LLC
Florida, United States
Nicholas Gonzalez, Cqe Cqa's Location
Miami-Fort Lauderdale Area, United States, United States
Nicholas Gonzalez, Cqe Cqa's Contact Details

Nicholas Gonzalez, Cqe Cqa work email

Nicholas Gonzalez, Cqe Cqa personal email

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."

Nicholas Gonzalez, Cqe Cqa's Current Company Details
Axiom Engineering Group LLC

Axiom Engineering Group Llc

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Owner and Principal Consultant - New Product Development and Quality Consulting
Florida, United States
Website:
medtronic.com
Employees:
10
Nicholas Gonzalez, Cqe Cqa Work Experience Details
  • Axiom Engineering Group Llc
    Owner And Principal Consultant - New Product Development And Quality Consulting
    Axiom Engineering Group Llc
    Florida, United States
  • Medtronic
    Program Management & Principal Consultant (Capa, Process Engineering, & Supplier Quality)
    Medtronic Oct 2016 - Present
    Minneapolis, Mn, Us
    Program 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.
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  • Medtronic
    Principal Consultant / R&D Consultant
    Medtronic Aug 2020 - Jul 2022
    Minneapolis, Mn, Us
    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 a site wide design CAPA. Created and presented company wide Design Control training.
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  • Mec Innovations
    Director Of New Product Development Quality
    Mec Innovations Oct 2016 - Present
    Fort Lauderdale, Florida, Us
    https://www.mecinnovations.com/
    View
  • Axiom Engineering Group Llc
    Owner / Principal Consultant - New Product Development / Quality Consulting
    Axiom Engineering Group Llc Mar 2010 - Present
    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 free to reach out.Such clients include;Medtronic - Intersect ENT (Menlo Park, CA)Abbott Laboratories Vascular-Structural Heart Division (Menlo Park, CA)ImmunoSite (Ft. Lauderdale, FL)Boston Scientific Corporation (Doral, FL & Marlborough, MA)American Medical Systems (Minnetonka, MN)Intelligent Hearing Systems (Miami, FL)AngioDynamics (Latham, NY)Brisa Medical (Miami, FL)Triomi Medical Innovation (Oakville, ON)
  • Beckman Coulter
    New Product Development Core Team Lead - Staff Quality Engineering
    Beckman Coulter Nov 2013 - Oct 2016
    Brea, California, Us
    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.
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  • Goode Compliance International
    Program Manager- Quality
    Goode Compliance International Mar 2010 - Sep 2013
    Fort Lauderdale, Fl, Us
    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.
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  • Florida Power & Light
    Project Engineer
    Florida Power & Light Jun 2007 - Mar 2010
    Juno Beach, Fl, Us
    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.
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  • Goode Consulting International
    Quality Engineer
    Goode Consulting International May 2006 - Jun 2007
    Fort Lauderdale, Fl, Us
    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.
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Nicholas Gonzalez, Cqe Cqa Skills

Validation V&v Medical Devices Six Sigma Quality Assurance Design Control Iso 13485 Fmea Fda Capa Quality System Root Cause Analysis Failure Modes Minitab Statistics Iso 14971 Gage R&r Test Methodologies Project Management Design Of Experiments Dmaic Process Validation Quality Engineering Quality Management Risk Management Gmp Certified Quality Engineer Iso Quality Control Product Development Risk Assessment Autocad Testing Biomedical Engineering Leadership Corrective And Preventive Action Management

Nicholas Gonzalez, Cqe Cqa Education Details

  • Harvard Business School
    Harvard Business School
    Core : Credential Of Readiness"
  • University Of Miami
    University Of Miami
    Mechanical Engineering

Frequently Asked Questions about Nicholas Gonzalez, Cqe Cqa

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 the current company?

Nicholas Gonzalez, Cqe Cqa's current role is Owner and Principal Consultant - New Product Development and Quality Consulting.

What is Nicholas Gonzalez, Cqe Cqa's email address?

Nicholas Gonzalez, Cqe Cqa's email address is ni****@****nic.com

What schools did Nicholas Gonzalez, Cqe Cqa attend?

Nicholas Gonzalez, Cqe Cqa attended Harvard Business School, University Of Miami.

What skills is Nicholas Gonzalez, Cqe Cqa known for?

Nicholas Gonzalez, Cqe Cqa has skills like Validation, V&v, Medical Devices, Six Sigma, Quality Assurance, Design Control, Iso 13485, Fmea, Fda, Capa, Quality System, Root Cause Analysis.

Who are Nicholas Gonzalez, Cqe Cqa's colleagues?

Nicholas Gonzalez, Cqe Cqa's colleagues are Christiaan Snijders, Kodie Lafave, María Rubio García, Florent Legrenzi, William Hunsucker, Mba, Ccds, Pelin Unal, Carlos (Charlie) Erdmann.

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