Liz Kinnal

Director of Quality at Selux Diagnostics

Liz Kinnal has a wealth of experience in the medical device industry. Liz began their career in 2006 as an Engineering Intern R&D Endoscopy at Boston Scientific, where they compiled all previous data from project team into usable documents and created a test method to test product material for pushability. Liz then returned to Boston Scientific in 2007 as an Engineering Intern R&D Oncology, where they were responsible for test method revisions in compliance with FDA standards, retested current market products to validate according to FDA standards, and created test fixtures using Solid Works and wrote corresponding test methods. In 2008, they worked as a Patent Examiner at the US Patent and Trademark Office and as a Design Engineer at Optim, where they were the lead designer on product modifications and responsible for designing the modifications, documenting the changes using ISO 9000 procedures and FDA guidelines, implementing the changes on the manufacturing floor, and working with the Sales and Marketing division to best market the improved product. Liz then moved to 480 Biomedical, Inc. in 2013, where they were a Senior Quality Engineer and Quality Engineer II. In their roles, they were the quality lead for internal product development team and integrated OEM development team, developed and implemented quality systems compliant to ISO 13485:2003 and 21 CFR 820, and supported regulatory submissions to TGA and various European Geographies. Liz then joined Access Vascular, Inc. in 2017 as Manager, Quality and Regulatory and Senior Regulatory Affairs and Quality Engineer. Her current role is Director of Quality at Selux Diagnostics, Inc., where they are responsible for developing technology that will enable clinicians to administer personalized therapies to infection disease patients within hours rather than days and supports efforts to improve patient care, shorten hospital stays, and combat the growing antibiotic resistance epidemic.

Liz Kinnal obtained a degree in Biomedical Engineering from Worcester Polytechnic Institute in 2008. In 2014, they obtained a Industrial Wastewater Treatment Plant Operator - Grade 1 certification from the Massachusetts Board of Certification of Wastewater Treatment Plant Operators and a Certified Quality Auditor certification from ASQ.

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Previous companies

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Timeline

  • Director of Quality

    November, 2022 - present

  • Quality Manager

    February, 2019

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