Experienced, certified, professional Quality Auditor. Performing comprehensive internal audits, gap analysis and quality system implementations. Working with large and small companies since 2014. Focusing on companies in general manufacturing, medical devices, finished pharmaceuticals, and aerospace. Over 30 years of business experience with B.S. in Business Management.Quality Standards audited: ISO 9001:2015 Quality Management System; 13485:2016 Medical Devices; AS9100D Aerospace Design and Manufacturing; AS9110 Aerospace Distributors; FDA 21 CFR Part 820 Quality System; FDA QMSR; AS9110 Aerospace Maintenance; European EU 2017/745 Medical Device Regulation; European EU 2017/746 In Vitro Diagnostics Medical Devices; and GMP Finished Pharmaceuticals 21 CFR 210 and 211.