Lyndon White Email and Phone Number
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Experienced QA/RA leader with a demonstrated history of working in the biotechnology industry. Skilled in Medical Devices (IVD), Biotechnology, Laboratory Medicine, Life Sciences, and Microscopy. Strong legal professional with a Master’s Degree focused in Biotechnology from The Johns Hopkins University.
Luminex Corporation - A Diasorin Company
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Senior Manager, Post Market SurveillanceLuminex Corporation - A Diasorin Company Nov 2021 - PresentAustin, Tx, Us
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Lead Quality AuditorLuminex Corporation - A Diasorin Company Nov 2010 - PresentAustin, Tx, UsLead audits and effectiveness checks as required by the Luminex Quality Management System [QMS] utilizing 21 CFR, CMDR, MDSAP, and ISO 13485 guidance.
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Manager, Regulatory AffairsLuminex Corporation - A Diasorin Company Apr 2019 - Dec 2021Austin, Tx, UsResponsibility for supporting and maintaining regulatory compliance for new product development and existing products. Assure adherence and certification of Luminex products to government and international regulatory requirements by working directly with National Recognized Testing Laboratories (NRTLs) to arrange for and monitor compliance certification testing. Develop regulatory submissions and assessments (in compliance with applicable regulations and standards) to ensure timely global commercialization of products.Advise colleagues on international regulation requirements like RoHS, REACH, CE, EMC, and relevant domestic standards such as Prop 65 and the Dodd-Frank Act involving Luminex products.
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Senior Regulatory Affairs AssociateLuminex Corporation - A Diasorin Company Jan 2017 - Apr 2019Austin, Tx, Us
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Post Market Vigilance Clinical AnalystLuminex Corporation - A Diasorin Company Jun 2014 - Dec 2016Austin, Tx, UsIndividually responsible for reviewing and trending on-market complaints [~15,000 records reviewed annually] relative to the identity, quality, reliability, safety, and effectiveness of Luminex IVD products. In addition, I provided technical expertise and oversight during the capture and investigation of product complaints to best comply with adverse event, recall, and customer notification requirements as dictated by current FDA and international reporting regulations (EU, HC, China SFDA).Data obtained from IVD product complaint analysis was further fed into the Luminex Quality Management System and regularly presented to executive leadership. Common outputs included CAPAs, Customer Advisories, and Technical Field Bulletins.
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Technical Specialist, DiagnosticsLuminex Corporation - A Diasorin Company Nov 2010 - Jun 2014Austin, Tx, UsResponsible for leading technical investigations and providing issue resolution for complaints sourced from both external and internal clients. Provided one-on-one instrument and software training to supplement the new customer experience. Performed laboratory work in support of diagnostic product investigations and coordinated with other departments for customer management and expedited issue resolution.Served as Subject Mater Expert for MAGPIX, ARIES, LX200, and IS / xPONENT software. Authored content to Salesforce Knowledge Management database and Oracle FAQ database. Contributed to CAN, TSB, FSA, and CAPA processes as required.
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Medical Laboratory ScientistTexas State University Jan 2010 - Sep 2010San Marcos, Tx, UsPerformed highly complex chemical, biological, hematological, immunological, and molecular diagnostic patient testing. Specialized in Immunology, Hematology, and Clinical Microbiology.Kept accurate records of quality control, maintenance, and workload data according to laboratory policy and procedures. Interpreted and reported QC statistical data using Levy-Jennings charts and Westgard rules. Conserved knowledge of CLIA, HIPAA, OSHA requirements and presented updated training to new medical laboratory scientists and technologists. Conducted routine maintenance on laboratory equipment and provided quality control data for all reagents and testing methods. -
Technical Support SpecialistApple May 2005 - Sep 2006Cupertino, California, UsDirect customer and internal support of Apple hardware and OSX operating system.Troubleshoot simple to complex issues while adapting to a variety of skill levels through a positive, analytical, and informative approach. Responsible for reporting emerging software and hardware issues to the appropriate engineering team and assist in driving the solutions to impacted users. -
Americas Transactional Group (Atg) Sales RepresentativeDell Jan 2004 - May 2005Round Rock, Texas, UsTeam mentor responsible for improving Training product attach rate for EPP Sales Team.Responsible for motivating and enabling new EPP Sales Representatives to reach their full potential through sales coaching, soft-skill exercises, and presenting successful closing techniques. -
Security Consultant (Sales Representative / Technical Support)Supercircuits, Inc. 2002 - 2005Trained and mentored sales representatives on effective sales presentations, success strategies, and closing methods with concentration on customer needs and satisfaction. Personally accountable for 11% of company revenue in 2004 with contracts totaling $3.1 million. Disseminated knowledge of Federal Code of Regulation (CFR) FCC Part 15 and Part 90 to sales representatives exposed to law enforcement and government agencies. Provided in-depth customer training and on-site product installation support for mission critical covert operations.
Lyndon White Skills
Lyndon White Education Details
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The Johns Hopkins UniversityBiotechnology -
Texas State UniversityMedical Laboratory Science
Frequently Asked Questions about Lyndon White
What company does Lyndon White work for?
Lyndon White works for Luminex Corporation - A Diasorin Company
What is Lyndon White's role at the current company?
Lyndon White's current role is Senior QA/RA Leader with extensive IVD Medical Device Experience..
What is Lyndon White's email address?
Lyndon White's email address is lw****@****orp.com
What schools did Lyndon White attend?
Lyndon White attended The Johns Hopkins University, Texas State University.
What are some of Lyndon White's interests?
Lyndon White has interest in Agricultural Genomics, Hematology, Microbiology, Industrial Biotechnology.
What skills is Lyndon White known for?
Lyndon White has skills like Microbiology, Immunology, Troubleshooting, Life Sciences, Laboratory Medicine, Laboratory, Hardware Diagnostics, Immunoassays, Molecular Biology, Assay Development, Genomics, Hematology.
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