Olga Engel

About Olga Engel

Accomplished and results-driven Engineer with experience in APQP/PPAP design controls, risk management, and process validation. Proven track record in leading design assurance for ISO/FDA/EU compliant products, including FMEAs, design verification/validation. Adept at collaborating with R&D, manufacturing, and regulatory teams to drive new product introduction and design transfers. Able to travel extensively, comfortable working with and in different countries.Skills: Requirements Definition, Audits Internal/External 2nd & 3rd party Notified Bodies, Six Sigma, 8D, 5S, Lean, APQP, PPAP, DFMEA, PFMEA, FAIR, V&V, SPC, DOE, DFM, DFS, VAVE, IQ/OQ/PQ, MSA, Gage R&R studies, Risk Assessment, Root Cause Analysis, CAPA, Gemba, Kaizen, DMAIC, Value Stream Analysis, Project Management.ISO/IEC 9001, 13485, 27001, 14971, 24971, 17025, 10993-1, 45001, 42001, 42005, 14001, 14644-1, MDD 93/42/EEC, 62366, EU MDD/MDR, AS9145, AS9102, ASQ Z1.4, NIST 800-53, NIST 800-30//161/71/72, FDA’s EUA, AIMS, ISMS, EU ACT, CMMC Frameworks, CIS Controls, DOD CUI/PII.Able to travel extensively; comfortable working with and in different countries.

Experience

1. Quality Engineer

   Precision Castparts

   Sep 2025 — Present

   PCC Rollmet is a leader in the development and manufacture of defense and missile-related products. Warren Buffett‘s Berkshire Hathaway Inc. NYSE:BRK

Education

• National Technical University "Kharkiv Polytechnic Institute"

  Bachelor of Science (BS) and Master of Science (MS), Materials Science in Mechanical Engineering

• Simon Kuznets Kharkiv National University of Economics

  Bachelor of Science (BS) and Master of Science (MS), Industrial Systems Engineering & Management