Quality Systems Specialist I, Digital Health
WhoopWearable Technology company
Boston, United States$105,000 - $135,000Mid
Collaborative Fund
2PointZero Group
Qatar Investment Authority
Mubadala
Abbott
Mayo Clinic
Software Engineering
About the role
TL;DR
Maintain and improve WHOOP's Quality Management System for digital health products.
- •WHOOP is seeking a Quality Systems Specialist I to join the Digital Health team.
- •This role is crucial for maintaining and improving the Quality Management System (QMS) for SaMD and digital health products, ensuring compliance with global regulations.
- •Key Responsibilities Own and maintain QMS processes in compliance with ISO 13485, 21 CFR Part 820/QMSR, MDSAP, and IEC 62304.
- •Administer and maintain the eQMS, including document control, post-market workflows, and training management.
- •Own core quality system processes such as complaint management, CAPA, nonconformances, and change control.
- •Drive timely closure of CAPAs, nonconformances, and audit findings.
- •Maintain audit and inspection readiness and coordinate internal and external audits.
- •Requirements Bachelor's Degree in Engineering, Life Sciences, or a related technical field. 2+ years of experience in Quality Management Systems or related functions in the medical device/digital health industry.
- •Working knowledge of ISO 13485 and 21 CFR Part 820/QMSR.
- •Experience owning and administering quality system processes (CAPA, complaints, audits, training, document control).
- •Experience supporting electronic Quality Management Systems (eQMS).
Domain expertise
healthtech
Benefits & perks
equity, benefits