Description
The Quality Engineer II, Sustaining supports quality and regulatory compliance for ICU products in a regulated manufacturing and healthcare environment. The role validates manufacturing equipment, processes, software, and test methods using IQ/OQ/PQ protocols; performs risk assessments, process FMEAs, quality control planning, audits, and quality-system documentation; and supports compliance with FDA regulations, ISO 13485, ISO 14971, and related company requirements. It requires a STEM bachelor’s degree, 2–4 years of regulated manufacturing or pharmaceutical/healthcare experience, and proficiency with Minitab, Microsoft Office, validation tools, and statistical analysis.
