Quality Engineering Manager

Summary

This role leads quality engineering strategy and operations for a medical device design center, overseeing compliance with FDA regulations (21 CFR 820, ISO 13485, ISO 14971) and managing a team of Quality Engineers. The manager develops and sustains quality management systems, executes quality initiatives, provides statistical and design-control expertise, and drives continuous improvement. The position requires ten years of progressive QA experience in FDA-regulated industries, three years of direct management experience, and deep knowledge of design controls, risk management, and quality engineering methodologies.