Linda Guthrie

Linda Guthrie Email and Phone Number

Manager Quality Assurance Engineer at Mizuho OSI @ Mizuho OSI
Linda Guthrie's Location
Palo Alto, California, United States, United States
Linda Guthrie's Contact Details

Linda Guthrie personal email

About Linda Guthrie

Linda Guthrie is a Manager Quality Assurance Engineer at Mizuho OSI at Mizuho OSI. She possess expertise in quality system, clinical trials, iso 13485, fda, ce marking and 12 more skills. Colleagues describe her as "Linda has a wide breadth of medical device RA/QA and Operations knowledge that she brings to every critical business decision. She is very experienced with complying with regulations while balancing the time and resource constraints of early stage companies. Linda can juggle a wide range of responsibilities and transition back and forth between the details and the strategy of building internal processess and systems. She was a great asset to the management team."

Linda Guthrie's Current Company Details
Mizuho OSI

Mizuho Osi

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Manager Quality Assurance Engineer at Mizuho OSI
Linda Guthrie Work Experience Details
  • Mizuho Osi
    Manager Quality Assurance Engineer
    Mizuho Osi Jan 2016 - Present
    Union City, Ca, Us
    Maintain existing Quality System; generate reports of trend analysis and statistical distribution for manufacturing process audits and product audits. Participate in the development and implementation of new procedures for plant quality systems. Coordinate and support the internal audit program. Participate in and/or manage corrective and preventative action processes for both internal and external suppliers. Implement change and review current processes throughout the organization to enhance overall performance.
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  • Artheromed Inc
    Sr Manager Ra/Qa
    Artheromed Inc Mar 2013 - Jan 2016
    Responsible for maintaining all aspects of the ISO certified quality system. Directly responsible for Document Control, IQC, CAPA/NCMRs, Supplies Assessments, Internal Audits, etc. Responsible for creating and maintaining Technical File for new product and maintaining the CE mark for existing product. Direct support and input for 510(k) submissions, actively involved with project teams providing quality support and regulatory strategy.
  • Abaxis
    Regulatory Affairs/Quality Assurance Consultant
    Abaxis Oct 2012 - Feb 2013
    Union City, Ca, Us
    Responsible for Document Control, created training plans, conducted internal audits, involved with CAPAs and International RA including Canada, Mexico, and Asia Pacific. (IVD medical device). Reason for leaving; assignment completed.
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  • Ouroboros Medical
    Director Ra/Qa
    Ouroboros Medical Oct 2011 - Jun 2012
    Maintain existing Quality System; generate reports of trend analysis and statistical distribution for manufacturing process audits and product audits. Implement change and review current processes throughout the organization to enhance overall performance. Coordinate and support the internal audit program. Participate in and/or manage corrective and preventative action processes for both internal and external suppliers.
  • Nellix Endovascular
    Director Ra/Qa
    Nellix Endovascular 2009 - 2011
    Us
    Created and maintainted ISO ISO certificatied Quality System. Created Design Dossier, led CA FDB inspection. Active member on project teams providing regulatory support and strategy for domestic and international market clearances.
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  • Sentreheart, Inc.
    Manager Ra/Qa
    Sentreheart, Inc. 2006 - 2009
    Created and maintained ISO certified Quality System. Obtained US market clearance via 510(k), CE Mark Approval via Design Dossier and approval in Canada via Candian product license applications Actively involved with project teams providing quality support and regulatory strategy.
  • Rita Medical
    Manager Ra/Qa
    Rita Medical 2004 - 2006
  • Artemis Medical
    Manager Ra/Qa
    Artemis Medical 2003 - 2004
  • Oratec Interventions
    Manager Ra/Qa
    Oratec Interventions 2000 - 2003
  • Target Therapeutics
    Sr Ra Specialist
    Target Therapeutics 1993 - 2000
  • Psg/Advanced Cardiovascular Systems
    Ra/Qa Associate
    Psg/Advanced Cardiovascular Systems 1988 - 1993

Linda Guthrie Skills

Quality System Clinical Trials Iso 13485 Fda Ce Marking Design Control Gmp V&v Capa Medical Devices Commercialization Iso 14971 21 Cfr Part 11 Biomedical Engineering Validation Regulatory Affairs Verification And Validation

Frequently Asked Questions about Linda Guthrie

What company does Linda Guthrie work for?

Linda Guthrie works for Mizuho Osi

What is Linda Guthrie's role at the current company?

Linda Guthrie's current role is Manager Quality Assurance Engineer at Mizuho OSI.

What is Linda Guthrie's email address?

Linda Guthrie's email address is li****@****xis.com

What skills is Linda Guthrie known for?

Linda Guthrie has skills like Quality System, Clinical Trials, Iso 13485, Fda, Ce Marking, Design Control, Gmp, V&v, Capa, Medical Devices, Commercialization, Iso 14971.

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