Quality Systems Specialist I, Digital Health

Whoop
Boston
Workplace: OnsiteFull timeUSD 105,000 - 135,000 annuallyFunction: Quality & Regulatory (Non-Software)Experience: 2+ yearsEducation: bachelorsSkills: ["Organizational","Communication","Project management"]

Maintain and continuously improve a Quality Management System (QMS) for software as a medical device (SaMD) and digital health products. Own key QMS processes including ISO 13485- and 21 CFR Part 820/QMSR-aligned procedures, eQMS administration, and CAPA/complaint and audit activities. Coordinate internal and external audits, support management reviews, and drive continuous improvement through trend analysis, root-cause investigations, and quality metric monitoring.

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FursaFursa
Whoop
Whoop
1 week ago

Quality Systems Specialist I, Digital Health

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Job Summary

Maintain and continuously improve a Quality Management System (QMS) for software as a medical device (SaMD) and digital health products. Own key QMS processes including ISO 13485- and 21 CFR Part 820/QMSR-aligned procedures, eQMS administration, and CAPA/complaint and audit activities. Coordinate internal and external audits, support management reviews, and drive continuous improvement through trend analysis, root-cause investigations, and quality metric monitoring.
Location: Boston
Workplace: Onsite
Employment Type: Full time
Job Function: Quality & Regulatory (Non-Software)
Seniority: Entry level

Key Responsibilities

  • •Own and maintain QMS processes in compliance with ISO 13485, 21 CFR Part 820/QMSR, MDSAP, IEC 62304, and applicable requirements for 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 by coordinating internal/external audits, supporting management reviews, and monitoring quality metrics to drive continuous improvement.

Pay and Benefits

Salary: USD 105,000 - 135,000 annually
Equity and Bonus:Equity

Key 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 in medical devices, digital health, or software medical device.
  • •Working knowledge of ISO 13485 and 21 CFR Part 820/QMSR; experience with MDSAP and IEC 62304 preferred.
  • •Experience owning and administering quality system processes such as CAPA, complaints, audits, training, and document control.
  • •Experience supporting and maintaining an electronic Quality Management System (eQMS) and supporting internal/third-party audits and regulatory inspections.
Experience:2+ yearsMedical deviceDigital healthSaMDSoftware medical deviceQuality management systems
Education:Bachelor's
Skills:OrganizationalCommunicationProject management
Tech Stack:ISO 1348521 CFR Part 820/QMSRMDSAPIEC 62304QMSEQMSCAPADocument controlComplaint managementSaMDPost-market surveillanceAudit readinessRoot cause investigationsTraining managementChange control

Company Brief

Whoop
Whoop designs and sells a subscription-based wearable fitness tracker and analytics platform that monitors recovery, strain, and sleep to optimize athletic performance and daily health for consumers and professional athletes.
Industry: Wearables
Company Size: Large (251 to 1,000 employees)
Growth: Scaleup
Valuation: Unicorn (USD 1B+)
Funding: Series E+
Headquarters: Boston, United States
Founded: 2012
WebsiteLinkedIn