Quality Assurance Manager

We are seeking a forward-thinking Quality Manager to lead Quality operations across our Americas Fulfillment Network. This role will drive the implementation and continuous improvement of a multi-site Quality Management System (QMS) within a regulated environment, partnering closely with Operations, Supply Chain, and Global Quality leadership.Key ResponsibilitiesLead Quality across multiple fulfillment sites (Moreno Valley, Atlanta, Indianapolis)Drive compliance with ISO 13485 and global regulatory standardsPartner cross-functionally with Operations, Transportation, Regulatory, and 3PL partnersOwn audits, CAPA, nonconformances, and investigationsDeliver quality insights, risk assessments, and recommendations to leadershipLead continuous improvement, standardization, and QMS modernization (automation, digital tools, analytics)Required QualificationsBachelor’s degree in Engineering, Science, Operations, or related field7+ years leading Quality in a multi-site, regulated environmentStrong experience with ISO 13485 (or equivalent QMS)Hands-on leadership of CAPA, nonconformances, and structured problem solving (A3, 8D, DMAIC)Proven ability to lead audits and influence cross-functional stakeholdersPreferred QualificationsMedical device or pharmaceutical industry experienceLean / Six Sigma or continuous improvement backgroundExperience with digital transformation, automation, or AI-driven quality tools