Quality Systems Specialist I, Digital Health

WHOOP is an advanced health and fitness wearable on a mission to unlock human performance. We empower our members to improve their health and perform at a higher level through a deeper understanding of their bodies and daily lives. WHOOP is looking for a Quality Systems Specialist I to be a core member of the Digital Health team at WHOOP. As the Quality Systems Specialist I, you will maintain and continuously improve WHOOP's Quality Management System (QMS) for Software as a Medical Device (SaMD) and digital health products. This role owns key quality system processes and helps ensure compliance with applicable global regulations and standards. You will play a critical role in maintaining an effective, scalable quality system that supports innovation while ensuring product quality and regulatory compliance.

RESPONSIBILITIES

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. Develop, review, maintain, and improve SOPs, work instructions, forms, and other controlled documentation. Monitor evolving regulatory and quality requirements and support implementation of necessary QMS updates.

QUALIFICATIONS

Bachelor's Degree in Engineering, Life Sciences, or a related technical field. 2+ years of experience in Quality Management Systems, Quality Assurance, or related functions within the medical device, digital health, or software medical device industry. 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. Experience owning and administering quality system processes such as CAPA, complaints, audits, training, and document control. Experience supporting and maintaining electronic Quality Management Systems (eQMS). Experience supporting internal audits and third-party audits, including regulatory inspections. Experience with SaMD, digital health technologies, software development lifecycle processes, and software-focused quality systems 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. WHOOP is an Equal Opportunity Employer and participates in E-verify to determine employment eligibility. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. The WHOOP compensation philosophy is designed to attract, motivate, and retain exceptional talent by offering competitive base salaries, meaningful equity, and consistent pay practices that reflect our mission and core values. At WHOOP, we view total compensation as the combination of base salary, equity, and benefits, with equity serving as a key differentiator that aligns our employees with the long-term success of the company and allows every member of our corporate team to own part of WHOOP and share in the company’s long-term growth and success. The U.S. base salary range for this full-time position is $105,000 - $135,000. Salary ranges are determined by role, level, and location. Within each range, individual pay is based on factors such as job-related skills, experience, performance, and relevant education or training. In addition to the base salary, the successful candidate will also receive benefits and a generous equity package. These ranges may be modified in the future to reflect evolving market conditions and organizational needs. While most offers will typically fall toward the starting point of the range, total compensation will depend on the candidate’s specific qualifications, expertise, and alignment with the role’s requirements. #J-18808-Ljbffr Whoop