Quality Systems Specialist I, Digital Health

About the role

This position is a critical quality role embedded within the Digital Health team at WHOOP, focused on the integrity of our software as a medical device (SaMD) and digital health product offerings. The hire will be responsible for owning and maintaining the end-to-end Quality Management System (QMS) to ensure it remains robust, effective, and compliant with global regulatory standards. You will drive continuous improvement initiatives designed to enhance process efficiency and product quality across the digital health lifecycle. This role requires a proactive mindset to manage complex quality processes and ensure seamless execution across cross-functional teams. You will serve as the primary point of contact for quality system compliance for digital health products. The position demands a detail-oriented individual who can balance rigorous regulatory requirements with the fast pace of product innovation. Ultimately, this role ensures that WHOOP's commitment to human performance is backed by a compliant and reliable quality infrastructure.

Key facts

What you'll do

Coordinate and execute all aspects of the eQMS, ensuring the system supports efficient document control, version management, and change control for digital health products.

Lead the administration of post-market workflows, including the management of field feedback, complaint trending, and signal detection to drive proactive quality improvements.

Own the execution of internal and external audit programs, preparing documentation, coordinating schedules, and ensuring timely resolution of audit findings.

Manage the CAPA process from initiation through closure, tracking nonconformances and ensuring all quality actions are resolved effectively and within defined timelines.

Develop and maintain controlled SOPs, work instructions, and forms, ensuring all quality documentation remains current and aligned with regulatory expectations.

Partner with Regulatory Affairs to monitor evolving global regulations such as ISO 13485, 21 CFR Part 820/QMSR, MDSAP, and IEC 62304 for impact on the QMS.

Support management reviews by compiling performance data, quality metrics, and trend analyses to inform strategic decisions and continuous improvement plans.

Collaborate with Engineering and Product teams to integrate quality system requirements into the software development lifecycle and product release processes.

Maintain records management practices to ensure the integrity, traceability, and secure retention of all quality-related data and documents.

Drive quality training programs, ensuring staff are adequately trained on procedures, changes, and regulatory requirements related to digital health products.

Perform root cause analysis investigations for nonconformances and quality events, implementing effective corrective and preventive actions to prevent recurrence.

Act as a liaison for third-party audits and inspections, ensuring WHOOP is consistently prepared to demonstrate compliance to regulatory bodies and certification schemes.

Analyze quality data and metrics to identify systemic issues and opportunities for process optimization across the SaMD and digital health product lines.

Support the implementation of MDSAP and other regulatory submissions by maintaining accurate and up-to-date quality documentation and evidence trails.

Champion initiatives to streamline QMS processes, leveraging technology and automation to improve efficiency and reduce manual overhead.

Requirements

Hold a Bachelor's Degree in Engineering, Life Sciences, or a related technical field as the foundational qualification for this role.

Bring a minimum of 2+ years of professional experience in Quality Management Systems, Quality Assurance, or similar roles within the medical device, digital health, or software medical device sectors.

Demonstrate working knowledge of ISO 13485 and 21 CFR Part 820/QMSR as the baseline regulatory standards for quality system management.

Possess prior experience owning and administering core quality system processes including CAPA, complaints handling, audits, training, and document control.

Have hands-on experience supporting and maintaining electronic Quality Management Systems (eQMS) platforms and associated workflows.

Show background in supporting internal audits, third-party audits, and regulatory inspections to ensure ongoing compliance readiness.

Preferably have direct experience with SaMD, digital health technologies, software development lifecycle processes, and software-focused quality systems.

Exhibit strong organizational, communication, and project management skills to manage multiple priorities in a dynamic environment.

Be prepared to relocate to the WHOOP office in Boston, MA, as this role requires onsite presence at the designated office location.

Nice to have

Experience with MDSAP, IEC 62304, and other applicable medical device regulations and standards is preferred for this position.

Familiarity with software development quality systems and specific digital health regulatory frameworks is advantageous.

Practical notes

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.