Braulio Ortiz

Braulio Ortiz Email and Phone Number

FDA, Regulatory Compliance, Quality, and Engineering Consultant for Medical Device & Pharmaceuticals @ SebastianStrong Foundation
Braulio Ortiz's Location
Miami, Florida, United States, United States
Braulio Ortiz's Contact Details
About Braulio Ortiz

Braulio has 30+ years of experience in quality assurance, engineering, and manufacturing in the biomedical, pharmaceutical, and medical device industries. He has vast experience in design, installation, and continuous improvement of 21 CFR and ISO 9001 compliant quality systems as well as successfully addressing FDA inspections, Consent Decree and Warning Letter responses. Expertise includes quality systems improvement strategies, Six Sigma, Business Process Re-Engineering, facilities commissioning, validation, and cost reduction initiatives.

Braulio Ortiz's Current Company Details
SebastianStrong Foundation

Sebastianstrong Foundation

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FDA, Regulatory Compliance, Quality, and Engineering Consultant for Medical Device & Pharmaceuticals
Braulio Ortiz Work Experience Details
  • Sebastianstrong Foundation
    Board Member
    Sebastianstrong Foundation Jun 2022 - Present
    Miami Springs, Fl, Us
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  • Bioteknica
    Principal
    Bioteknica 1996 - Present
  • Baxter Healthcare
    Director Of Operations
    Baxter Healthcare 1994 - 1996
    Deerfield, Illinois, Us
    View
  • Baxter (Dade) Diagnostics, Inc.
    Director Of Operations, Director Of Engineering
    Baxter (Dade) Diagnostics, Inc. 1983 - 1996
  • Baxter - Paramax Division
    Quality Systems Director
    Baxter - Paramax Division 1990 - 1992
  • Dade Diagnostics
    Operation Manager
    Dade Diagnostics 1987 - 1990
  • American Dade
    Project Engineer
    American Dade 1983 - 1986

Braulio Ortiz Skills

Validation Fda Quality System Medical Devices Quality Auditing Iso 13485 Quality Assurance Six Sigma Capa Engineering Manufacturing Design Control Fda Gmp Process Improvement V&v Computer System Validation Global Regulatory Compliance Iso 14971 21 Cfr Part 11 Expert Witness Hardware Diagnostics Certifications Fda Inspection Readiness

Braulio Ortiz Education Details

  • University Of Miami Herbert Business School
    University Of Miami Herbert Business School
    Executive Management
  • Cornell University
    Cornell University
    Chemical Engineering

Frequently Asked Questions about Braulio Ortiz

What company does Braulio Ortiz work for?

Braulio Ortiz works for Sebastianstrong Foundation

What is Braulio Ortiz's role at the current company?

Braulio Ortiz's current role is FDA, Regulatory Compliance, Quality, and Engineering Consultant for Medical Device & Pharmaceuticals.

What is Braulio Ortiz's email address?

Braulio Ortiz's email address is bo****@****ica.com

What is Braulio Ortiz's direct phone number?

Braulio Ortiz's direct phone number is +130579*****

What schools did Braulio Ortiz attend?

Braulio Ortiz attended University Of Miami Herbert Business School, Cornell University.

What skills is Braulio Ortiz known for?

Braulio Ortiz has skills like Validation, Fda, Quality System, Medical Devices, Quality Auditing, Iso 13485, Quality Assurance, Six Sigma, Capa, Engineering, Manufacturing, Design Control.

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