John E. Lincoln
Principal of J. E. Lincoln and Associates
Why you should listen
John has supported organizations from start-ups to Fortune 100 companies worldwide and specializes in quality assurance, regulatory affairs, and QMS remediation, including FDA responses and 510(k) submissions. His expertise also covers process/product/equipment validation, QMS and software validation, ISO 14971 risk management files, Design Controls/DHFs, and Technical Files. He has held leadership roles up to Director and VP (R&D), and brings additional experience in military, government, electronics, and aerospace. John has published widely (peer-reviewed journals, book chapters including RAPS), and has delivered workshops and webinars worldwide. He is a UCLA graduate.
