Hiring: Quality Systems Specialist I, Digital Health Company: WHOOP Location: Boston, MA Job Posted Time: 2026-09-12 11:48:42 Target Skills & Keywords : Product Lifecycle Management, Project Management, Quality Assurance, Regulatory Compliance About the job Experience: •2+ years of experience in Quality Management Systems, Quality Assurance, or related functions within the medical device, digital health, or software medical device industry. Required Skills: •Own and maintain QMS processes in compliance with ISO 13485, 21 CFR Part 820/QMSR, MDSAP, IEC 62304, and other applicable requirements supporting SaMD and digital health products. •Administer and maintain the eQMS, including document control, post-market workflows, training management, and system improvements. •Own core quality system processes including complaint management, CAPA and nonconformances, training, change control, records management, and QMS-related post-market quality activities. •Track and drive timely closure of CAPAs, nonconformances, audit findings, and other quality actions to ensure effectiveness and compliance. •Maintain audit and inspection readiness, coordinate internal and external audits, support management reviews, and monitor quality metrics and trends to drive compliance and continuous improvement. •Drive continuous improvement initiatives through data analysis, trend monitoring, root cause investigations, and process enhancements. •Partner cross-functionally to support post-market surveillance activities, complaint trending, and quality data analysis to ensure ongoing product quality and regulatory compliance. •Partner with Regulatory Affairs, Engineering, Product, and other functions to ensure quality system requirements are appropriately integrated into software development, product lifecycle management, and post-market activities. Qualifications: •Bachelor’s Degree in Engineering, Life Sciences, or a related technical field. •Solid functional working knowledge of ISO 13485 and 21 CFR Part 820/QMSR. Experience with MDSAP, IEC 62304, and other applicable medical device regulations and standards preferred. •Strong organizational, communication, and project management skills. •This role is based in the WHOOP office located in Boston, MA. The successful candidate must be prepared to relocate if necessary to work out of the Boston, MA office. •Interested in the role, but don’t meet every qualification? We encourage you to still apply! At WHOOP, we believe there is much more to a candidate than what is written on paper, and we value character as much as experience. As we continue to build a diverse and inclusive environment, we encourage anyone who is interested in this role to apply. Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!