Aaron Bilyeu Email & Phone Number

Nonconformance/CAPA Quality Engineer who supports, reviews, approves, and provides guidance for the Global CAPA process from a Policy/SOP and regulatory perspective. Drives updates to the CAPA process and provides support on the integration of CAPA throughout the companies processes (NC, complaints, audits, trigger processes, field actions, MDRs, Service, SCA, etc.). Heavy focus on risk based approach for CAPA escalation. I provide general guidance regarding regulations and standards and am skilled at interpreting and disseminating these requirements.Skilled at use of computer and navigation of QMS (SAP/Windchill), ERP(SAP) and CRM (Salesforce.com). Involved in software improvement and transition projects. I provide the quality approval for the implementation of new software for the business. Ensure GAMP 5, QMS, and 21 Part 11 compliance.As a bone marrow transplant survivor, I'm a proud Terumo Associate who is dedicated to ensuring others have the life saving procedure that I had.I began my career as global, then regional, technical (Electromechanical) support. I have a demonstrated history working in the medical device industry. Skilled in U.S. Food and Drug Administration (FDA), Corrective and Preventive Action (CAPA), Technical Support, Medical Devices, and Engineering. Strong information technology professional with a Bachelor of Science (BS) focused in Both Electronics and Computer Engineering Technology from DeVry University.

Listed skills include Medical Devices, Fda, Cross Functional Team Leadership, Manufacturing, and 21 others.