Job Description
WearLinq is hiring a Quality Manager to build, lead, and continuously improve our Quality Management System (QMS). This role is suited for a quality professional who thrives in a fast-paced, early-stage environment, influencing product development, regulatory readiness, and company culture. You will be responsible for maintaining compliance with FDA 21 CFR Part 820 and ISO 14971 , while also supporting design control, supplier qualification, risk management, and post-market processes. Key responsibilities include quality system development & compliance, design & development support, manufacturing & supplier quality, CAPA, nonconformance, and risk management. You will also contribute to post-market readiness, leadership & culture, and act as the company’s primary quality lead and FDA liaison. The role requires a Bachelor’s degree in engineering, life sciences, or related technical field, 5+ years of experience in medical device quality assurance, and proven knowledge of FDA 21 CFR Part 820 and ISO 14971.
About WearLinq
We are a growing medical device startup commercializing an FDA Class II device.