David Romano

Background

About David Romano

Innovative and versatile Senior QA Test Engineer and manager with diversified experience in a medical product development environment. ASQ CQE certification. Specialties include: • Authoring, reviewing, tracing and testing product requirements. • Playing a lead role in designing and maintaining the specifications and systems directed at product quality, defect prevention and troubleshooting. • Working with cross-functional teams to create test methods, conduct internal audits, support product and process root cause analysis and CAPA activities. • Strong knowledge of design controls and the product development cycle in an FDA regulated environment. • Actively leading new product development from concept through release to manufacturing. • Serving as technical lead in all areas of test, measurement and troubleshooting, root cause and corrective action. • Authoring test reports, test plans, test protocols, validation plans, validation protocols.• Performing validation testing, verification testing, and other activities involving quality, process, performance, durability, and reliability assessments. • Strong knowledge of statistical techniques relevant to testing and measurement including uncertainty specifications of metrology and calibration.