Stephanie Ortega

Stephanie Ortega Email and Phone Number

Product Manager at Asahi Intecc USA, Inc. @ Asahi Intecc USA, Inc.
Stephanie Ortega's Location
Santa Ana, California, United States, United States
Stephanie Ortega's Contact Details

Stephanie Ortega personal email

n/a
About Stephanie Ortega

Experienced product marketing and project management professional with a demonstrated history of working in the medical device and in vitro diagnostics industries. Skilled in Medical Devices, Biotechnology, Management, U.S. Food and Drug Administration (FDA), and Research and Development (R&D). Strong marketing experience backed by MBA from Chapman University, The George L. Argyros School of Business and Economics.

Stephanie Ortega's Current Company Details
Asahi Intecc USA, Inc.

Asahi Intecc Usa, Inc.

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Product Manager at Asahi Intecc USA, Inc.
Stephanie Ortega Work Experience Details
  • Asahi Intecc Usa, Inc.
    Marketing Manager, Medical Products
    Asahi Intecc Usa, Inc. Sep 2023 - Present
    Irvine, California, Us
  • Asahi Intecc Usa, Inc.
    Senior Product Manager
    Asahi Intecc Usa, Inc. Jan 2021 - Aug 2022
    Irvine, California, Us
  • Asahi Intecc Usa, Inc.
    Product Manager
    Asahi Intecc Usa, Inc. Apr 2019 - Dec 2020
    Irvine, California, Us
  • Hycor Biomedical Llc
    Senior Product Manager
    Hycor Biomedical Llc Sep 2017 - Apr 2019
    Garden Grove, California, Us
  • Hycor Biomedical Llc
    Franchise Manager, Allergy
    Hycor Biomedical Llc Aug 2016 - Apr 2019
    Garden Grove, California, Us
  • Hycor Biomedical Llc
    Senior Project Manager
    Hycor Biomedical Llc Jan 2014 - Aug 2016
    Garden Grove, California, Us
    Identify Process and Design Verification and Validation needs to transition project from R&D to production. Contract and manage several external sites for beta testing, regulatory and marketing studies. Collaborate with Marketing to align project build strategies with industry feedback to further commercialization plans.
  • Hycor Biomedical Llc
    Project Manager
    Hycor Biomedical Llc Sep 2012 - Dec 2013
    Garden Grove, California, Us
    Managed projects by developing design documents, creating project plans, and reporting weekly to management. Responsible for leading design reviews, facilitating regular team meetings, and tracking department progress. Participated in design of regulatory testing proposal for FDA PreSub meeting. Recruited, trained and supervised team of researchers. Interfaced on a regular basis with subcontracted manufacturer to align concurrent engineering efforts.
  • Hycor Biomedical Llc
    Senior Research Associate
    Hycor Biomedical Llc Dec 2009 - Aug 2012
    Garden Grove, California, Us
    Secured and supervised multiple contracts for product developmentParticipated in rework of design control procedures based on FDA and ISO guidancesResponsible for project documentation (PRDs) Designed assay development experiments and managed data review
  • The Princeton Review
    Mcat General Chemistry Classroom Instructor
    The Princeton Review Nov 2009 - Feb 2010
    New York, Ny, Us
  • A Wider Circle
    Public Housing Initiative Intern: Healthy Basics Education Team; Neighbor To Neighbor Intern
    A Wider Circle Jun 2009 - Aug 2009
    Silver Spring, Maryland, Us

Stephanie Ortega Skills

Fda R&d Immunoassays Validation Medical Devices Biotechnology Product Development Iso 13485 Life Sciences Elisa Lifesciences Cross Functional Team Leadership Immunology Management Gmp Project Management Design Control

Stephanie Ortega Education Details

  • Green Belt Six Sigma Certification
    Green Belt Six Sigma Certification
  • Chapman University
    Chapman University
    Master Of Business Administration (Mba)
  • Uc Irvine
    Uc Irvine
    Biological Sciences; Chemistry With A Concentration In Biochemistry

Frequently Asked Questions about Stephanie Ortega

What company does Stephanie Ortega work for?

Stephanie Ortega works for Asahi Intecc Usa, Inc.

What is Stephanie Ortega's role at the current company?

Stephanie Ortega's current role is Product Manager at Asahi Intecc USA, Inc..

What is Stephanie Ortega's email address?

Stephanie Ortega's email address is so****@****cal.com

What schools did Stephanie Ortega attend?

Stephanie Ortega attended Green Belt Six Sigma Certification, Chapman University, Uc Irvine.

What skills is Stephanie Ortega known for?

Stephanie Ortega has skills like Fda, R&d, Immunoassays, Validation, Medical Devices, Biotechnology, Product Development, Iso 13485, Life Sciences, Elisa, Lifesciences, Cross Functional Team Leadership.

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