Senior Quality Systems Engineer - Devices (QMS Lead)

Access Vascular, based in Massachusetts, seeks a Quality Engineer to oversee our QMS and provide quality engineering support across a small, hands-on team. You will drive compliance with FDA 21 CFR Part 820, ISO 13485, and ISO 14971, lead CAPA activities, enhance documentation and risk management, and partner with operations and suppliers to ensure validated, controlled processes. This role offers growth within a collaborative culture and exposure to post-market surveillance, audits, and