Everlywell is a digital health company at the forefront of biomarker intelligence, blending AI-driven technology with human expertise to provide personalized, actionable health insights. We simplify complex biomarker data into meaningful information, integrating advanced diagnostics, virtual care, and patient engagement to transform how and where healthcare is delivered.

Over the last ten years, Everlywell has generated nearly 1 billion personalized health insights, improving care for 60 million individuals and supporting hundreds of enterprise partners. In 2024 alone, approximately 1 in every 86 U.S. households used an Everlywell test, making us the leading at-home testing brand in the nation. And we’re just getting started. Powered by AI and designed to scale, we’re removing barriers, closing care gaps, and creating a smarter, faster, and more personalized healthcare experience.

This role, reporting to the Director of Regulatory and Quality Affairs, will oversee the quality management program for our diagnostic laboratory in Hoffman Estates, Illinois, ensuring compliance with regulatory standards and Everly Health’s quality management system. The Lab Quality Manager will provide leadership on CLIA, CAP, and NYS regulations, support the lab director in maintaining audit readiness, and collaborate across departments and with external regulatory bodies.

What You’ll Do:

– Maintain lab licensure and accreditation (CLIA, CAP, NYS) through renewals, applications, method submissions, and proficiency testing.
– Act as the primary contact between the lab and accrediting agencies.
– Manage document control, incident reporting, and personnel records.
– Review lab procedures and validation documents for regulatory compliance.
– Ensure lab personnel meet qualification standards.
– Conduct internal quality audits and implement corrective actions.
– Identify compliance risks and suggest process improvements.
– Resolve non-conformances and implement corrective/preventative actions.
– Lead quality system meetings and track key performance indicators.
– Collaborate with lab staff to provide training and ensure regulatory compliance.
– Oversee resolution of audit findings.
– Monitor and document deviations and corrective actions.
– Proactively manage quality risks and take corrective measures as needed.
– Serve as a regulatory resource for staff, maintaining up-to-date knowledge and offering guidance on compliance.

Who You Are:

– Hold a Bachelor of Science in medical technology, laboratory sciences, or a related field.
– Have at least 8 years of experience in clinical labs conducting moderate complexity in vitro diagnostic testing in a CLIA-certified environment.
– Possess strong documentation and organizational skills.
– Demonstrate sound judgment and the ability to work collaboratively in a team setting.
– Communicate effectively, both verbally and in writing, and thrive in a regulated environment.

The salary range for this role is $100,000 to $120,000, depending on qualifications, market data, location, and internal equity. The position also includes an annual bonus, health, dental, vision, and mental health insurance, 401(k) with company match, flexible PTO, a $100 monthly wellness stipend, and additional perks.