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Erika Horner is a Principal Quality Engineer at Mainstream Medical Devices, LLC. She possess expertise in customer service, public speaking, event planning, leadership, microbiology and 29 more skills.
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Principal Quality EngineerMainstream Medical Devices, Llc Mar 2024 - PresentAustin, Texas, Us
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Senior Quality EngineerBoston Scientific Dec 2023 - Mar 2024Marlborough, Ma, Us(Apollo Endosurgery Acquired by Boston Scientific in 2023) -
Senior Quality Assurance EngineerApollo Endosurgery Mar 2023 - Dec 2023Austin, Tx, Us -
Senior Quality EngineerDurastat Feb 2022 - Feb 2023Austin, Texas, UsPrimary responsibilities include supporting quality aspects of new and existing product development activities, ensuring that the performance and quality of products and services conform to established company, international and governmental regulatory standards, agency guidelines, and customer requirements by implementing and maintaining quality assurance policies, processes, procedures, and controls. -
Quality Assurance Engineer Ii At Smith & NephewSmith & Nephew Jan 2021 - Feb 2022Watford, Hertfordshire, Gb(Integra LifeScience Acquired by S&N in 2021) -Provide quality leadership to new product development and / or product support project teams as the quality engineering representative.-Work with a team to develop methods and procedures to ensure that the appropriate tests are conducted to assure that products meet the required specifications / standards and that the safety and reliability of products are established.-Generate / approve / manage design verifications, design validations, sterilization validations, process validations, supplier qualifications, test methods, capability studies, and risk management documentation.-Support manufacturing operations and provide expertise in product requirements, risk management, test methods, and statistical analysis.-Ensure compliance to product specific standards, including, but not limited to cGMP, QSR, US FDA, ISO, IEC, UL, EN, NMPA, and MDD / EU MDR requirements. -
Quality Assurance Engineer IiIntegra Lifesciences Dec 2019 - Jan 2021Princeton, New Jersey, Us -
Qc Associate IiLuminex Corporation Jul 2017 - Dec 2019Austin, Tx, Us -
Qc MicrobiologistXbiotech Usa, Inc. Jan 2016 - Jul 2017Austin, Texas, UsInvolved with ensuring cGMP compliance with all current procedures as well as support of the startup and commercial operation of the new biopharmaceutical manufacturing facility, including streamlining the manufacturing process, validating cleanroom, and method development/validation.Assisted with inventory control, purchasing and requesting of outsource testing by actively communication with third party vendorsResponsible for performing microbial and quality control testing for water systems,incoming reagents and growth medias, raw material and final product releaseSupported company in preparation for EMA inspections and audits by working together with quality assurance and clinical to ensure all documentation and practices were compliantGowned regularly in ISO 7- ISO 5 clean room to perform various tasks including environmental monitoring (personnel, surface, microbial air, and total particulate monitoring) and validation activities for compendial microbial methods as well as media fills -
Chemical AnalystSouthwest Research Institute Oct 2014 - Dec 2015San Antonio, Tx, UsPerformed quantitative and qualitative analysis of trace metals found in environmental, filters and water samples.Prepared samples using hot plate and acid digestions by EPA methodology (3010A, 3005A, 3050B, 200.7)Analyzed samples with ICP, ICP-MS, Atomic Absorption (perkin elmer, thermo) maintained these instruments including daily preventative maintenance and running controls and blanks to ensure accuracy.Interpreted data using the Laboratory Information Management System (LIMS) and creating reports for clients in format consistent with current FDA industry practicesDeveloped and revised lab TAPs (Test Analytical Procedures) for method improvements -
Lab TechnicianFood Safety Net Services Oct 2013 - Jun 2014San Antonio, Tx, Us- Knowledgeable about various methods complying with FDA and USDA protocols for handling samples contaminated with pathogens such as E.coli, Salmonella or Listeria. - Responsible for preparing proper media for various laboratory departments - Performs laboratory experimentation in the field of microbiology and chemistry(techniques such as different pathogen isolation methods, proper serial dilutions and first enrichments of samples with aseptic techniques)- Ensures quality control of laboratory procedures, staff communication, equipment functionality and OSHA/FDA compliance-Proficient in inputting the company’s data in Laboratory Information Management System (LIMS) and workflow approvals of samples received
Erika Horner Skills
Erika Horner Education Details
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The University Of Texas At San AntonioGeneral -
West Virginia State UniversityGeneral
Frequently Asked Questions about Erika Horner
What company does Erika Horner work for?
Erika Horner works for Mainstream Medical Devices, Llc
What is Erika Horner's role at the current company?
Erika Horner's current role is Principal Quality Engineer.
What is Erika Horner's email address?
Erika Horner's email address is eh****@****tat.com
What is Erika Horner's direct phone number?
Erika Horner's direct phone number is +121087*****
What schools did Erika Horner attend?
Erika Horner attended The University Of Texas At San Antonio, West Virginia State University.
What skills is Erika Horner known for?
Erika Horner has skills like Customer Service, Public Speaking, Event Planning, Leadership, Microbiology, Social Media, Research, Microsoft Office, Teamwork, Training, Wet Chemistry, Media Preparation.
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