Quality Management Systems Specialist

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Quality Management Systems Specialist based in United States.

This role serves as the operational backbone of a regulated Quality Management System within a software-focused medical device environment. You’ll keep an ISO 13485-compliant QMS running day to day while driving CAPA, NCR, document control, audits, and quality activities tied to software releases. The position offers broad cross-functional exposure, working closely with Engineering, Clinical Affairs, Regulatory, and other teams. You’ll help ensure products are released with complete documentation, traceability, and appropriate quality controls. The role also plays an important part in audit readiness, complaint-handling oversight, training, and continuous QMS improvement. This is a hands-on opportunity for a detail-oriented quality professional who enjoys owning processes, solving compliance challenges, and operating in a remote-first environment.