Kevin Posey
Active Member, Section and Division Management Leadership @Asq - World Headquarters
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WORK HISTORY
Active Member, Section and Division Management Leadership @Asq - World Headquarters
US
Audit Division Chair (elected), Jan 2020 - Jan 2021Audit Division Chair-elect, Jan 2019 - Dec 2019Audit Division Treasurer (elected), Jan 2016 - Dec 2019Education and Training Chair, Audit Division, May 2014-Dec 2018Innovation Interest Group Co-founder 2009-present, Secretary 20••••15Quality Management Division Technical Committee, 20••••13Pittsburgh Section Programs Chair 2011-13 Pittsburgh 2012 WCQI Conference Site Planning CommitteePittsburgh Biomedical Discussion Group co-founder 2008-09Dallas Section Programs 2006-07Member since 2006
EDUCATION
University of Southern California
MS, Systems Engineering
Lanier High School
HS Diploma, College/University Preparatory and Advanced High School/Secondary Diploma Program
Pennsylvania State University-Erie Campus
Plastics Injection Molding Engineering Seminars
California Polytechnic State University-San Luis Obispo
MS, Biomedical Engineering
The University of Texas at Austin
Bachelors of Science, Aerospace Engineering
Penn State University, Graduate School of Business
MBA, International Business Management
SKILLS
ABOUT KEVIN POSEY
Regulatory strategist for AI/ML powered MedTech products and services, Certified Negotiator and Mediator (qualified for Court appointment), Masters of Business Administration honors graduate (Beta Gamma Sigma), included in first passing group for new RAPS Certified Regulatory Compliance Certification (RCC-MDR) for MDR PRRC (Jan 2024), Certified Regulatory Affairs Professional RAC-Devices (August 23) and RAC-EU (Dec 2013), Regulatory Due Diligence for M&A, Six Sigma Green Belt and Lean Practitioner, Certified Quality Engineer, Software Quality Engineer, Biomedical/Device Auditor, Quality Auditor, Calibration Technician, Quality Technician, and Manager of Quality and Operational Excellence with 30+ years experience in product development and quality engineering as both an OEM and contract manufacturer for the Medical Device, In Vitro Diagnostics, Aerospace/Defense, Industrial Equipment, and Natural Resource industries. 20+ years experience in Medical Device quality engineering, management and leadership in the design, manufacture, and regulatory submission (US and International) support of Class I, II and devices. Engaging, highly qualified, and experienced trainer in quality disciplines and tools, Root Cause investigation, Corrective/Preventive Action, Software V&V, Computer Systems Validation, and more.Specialties: CSV, Software Quality Engineering/Assurance, Auditor Training, 3rd Party Audit Prep training, Successful Warning Letter and 483 response and remediation, Quality Management and Engineering, Regulatory Affairs, CE Marking, Biomedical Quality Audits, EMS Manufacturing and Quality, Statistical Analysis, Process validation, Supplier Quality Management, Acceptance sampling, Audits, QSR and ISO13485 Audits, Medical Device Risk Management, ISO14971 Audits, Medical Device Design Controls, Injection Molding, Verification and Validation, Device Software V&V, QMS Software Validation, Hardware V&V, 510K and PMA submissions authoring and support, Cardiac devices, Infusion devices, Respiratory devices, Orthopedic implants, In Vitro Diagnostics
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