Quality Systems Specialist I, Digital Health

Whoop•Boston, MA

6d•$105,000 - $135,000•Onsite

About The Position

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.

Requirements

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 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.
Strong organizational, communication, and project management skills.

Nice To Haves

Experience with MDSAP, IEC 62304, and other applicable medical device regulations and standards.
Experience with SaMD, digital health technologies, software development lifecycle processes, and software-focused quality systems.

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.