Brian Olea Email & Phone Number

Global Regulations and documentation expert, Lead Auditor/Consultant/Trainer/Inspector- ISO 9001, AS9100, AS9102, AS9110, ISO 13485, MDSAP, FDA, cGMP, IVDD – IVDR, ITAR, EASA, ANVISA, EU MDD-93-42-EEC, EU MDR (EU)2017/745, ROHS, REACH, 3TG, ARGMD, AS9102 and Certified for CAAC CCAR-145R3 (China), FAA repairmen certificate for limited radio.Create all controlled documentation and safeguards for FAA, CASA, EASA, FDA, cGMP, TGA, EU, AS9100, AS9110, AS9103, AS9115, AS9145, AS5553, ISO9001, MDSAP, and ISO13485. Lead and train employees in proper procedures and processes within the Quality Management System to drive Improvement. Liaison for outside Auditors and collaborate closely with customers for Auditing and Risk assessment in Aerospace and Medical Device Regulations. Assess and write Procedures based on relevant standards and regulatory requirements to verify compliance with regulatory and statutory bodies, perform quarterly audits as lead auditor as well as internal auditor, and approval of all documents. Using Customer requirements, Regulatory and Statutory requirements, keep records of testing such as Cpk verification, communicate with customers as to the validity of the machining process and updates to process controls. Write project specific procedures for customers as required, to verify compliance for regulatory bodies. Update and keep Quality Management Systems to follow current standards, creates Procedures, Work Instructions, Corrective Actions, Continual Improvement, Root Cause Analysis, Action Plans, updates to FAA/FDA and other regulatory body requirements by AS9100/FAA, ISO13485/FDA requirements. Write and give documentation for regulatory bodies as needed, while building relationships with those interested parties to better improve processes. Write and investigate non-conformities using various Root Cause Analysis techniques and reports to regulatory bodies as needed. Understanding of ITAR, FDA, CASA, CAAC, ANVISA, EU MDD-93-42-EEC, EU MDR (EU)2017/745 ARGMD, and FAA regulations and how they pertain to the industry.

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  Idaho State University

  Computerized Machining Technology