Everlywell is a digital health company pioneering the next generation of biomarker intelligence—combining AI-powered technology with human insight to deliver personalized, actionable health answers. We transform complex biomarker data into life-changing insights—seamlessly integrating advanced diagnostics, virtual care, and patient engagement to reshape how and where health happens.
Over the past decade, Everlywell has delivered close to 1 billion personalized health insights, transforming care for 60 million people and powering hundreds of enterprise partners. In 2024 alone, an estimated 1 in 86 U.S. households received an Everlywell test, solidifying our spot as the #1 at-home testing brand in the country. And we’re just getting started. Fueled by AI and built for scale, we’re breaking down barriers, closing care gaps, and unlocking a more connected healthcare experience that is smarter, faster, and more personalized.
The Sr. Quality Specialist plays a critical role in the execution and continuous improvement of Everlywells Quality Management System (QMS), ensuring compliance with FDA 21 CFR Part 820, ISO 13485, MDSAP, IVDR, and other applicable regulatory standards. This individual acts as a peer leader and subject matter expert within the Quality team, driving excellence in compliance, process performance, and audit readiness across Everly’s regulated manufacturing and diagnostics operations. While not a supervisory role, the Sr. Quality Specialist will mentor and coach peers, champion cross-functional problem solving, and lead quality initiatives.
Quality Systems & Compliance Responsibilities: Drive execution of assigned QMS processes (e.g., document control, CAPA, internal audits, nonconformance investigations, supplier quality).Monitor, interpret, and ensure alignment to evolving FDA regulations (21 CFR Part 820), ISO 13485, IVDR, and applicable guidance.Lead and support internal and external audits (e.g., FDA, notified body, customer), including audit readiness, hosting, and CAPA management.Conduct and lead supplier quality audits, ensuring compliance with Everly’s supplier quality requirements.Perform gap assessments of QMS elements and lead improvement projects to close compliance gaps.
Manufacturing Quality Responsibilities:Support incoming inspection and final product release of regulated test kits and diagnostic components.Partner with Manufacturing, Supply Chain, and Laboratory teams to address quality issues, implement root cause analysis (e.g., 5 Whys, Fishbone, FMEA), and prevent recurrence.Lead quality review of deviations, non-conformances, change control, and validation activities in alignment with GMP.This salary range for this position is $85,000 - $102,000 based on the selected candidate's qualifications, market data/ranges, location, and internal equity. This position is also eligible for an annual bonus, health, dental, vision & mental health insurance, 401(k) with company match, Flexible PTO, a monthly $100 wellness stipend and various other perks.
