Summary from listing
The Quality Engineer will lead and maintain the company’s medical device quality management system for biomagnetic hardware and software, including document control, design controls, risk management, CAPAs, audits, supplier qualification, regulatory submissions, and continuous improvement. The role requires a bachelor’s degree or above in engineering, 7–10 or more years of related quality assurance or development support experience, and proficiency with medical device quality standards such as ISO 13485, ISO 14971, FDA 21 CFR 820, and ANSI/IEC 62304. The position involves cross-functional leadership, occasional travel, and work in a fast-paced small-team environment.
