Lab Quality Manager for Moderate Complexity CLIA Lab

Lab Quality Manager for Moderate Complexity CLIA Lab

Everlywell is a digital health company pioneering the next generation of biomarker intelligencecombining AI-powered technology with human insight to deliver personalized, actionable health answers. We transform complex biomarker data into life-changing insightsseamlessly integrating advanced diagnostics, virtual care, and patient engagement to reshape how and where health happens. Reporting to the Director of Regulatory and Quality Affairs, this position will lead the quality management program for our Hoffman Estates-based diagnostic laboratory in accordance with the regulatory standards and the quality management system at Everly Health. The Lab Quality Manager will provide leadership and guidance regarding CLIA, CAP, NYS and associated regulations, and support the lab director and leadership in maintaining audit readiness. The position requires extensive cross-functional interaction, strong liaison activities with laboratory leadership, as well as with external notified bodies and third parties including CLIA, CAP, New York State and other regulatory authorities. This role is based out of Hoffman Estates, Illinois.

What You'll Do

• Maintain laboratory licensure and accreditation (CLIA, CAP, NYS) through periodic renewals, new applications, method submissions and managing the proficiency testing program.
• Serve as the liaison between the clinical laboratory and accrediting agencies.
• Administer and manage the document control system, incident reporting system and personnel documentation.
• Review all laboratory procedures and validation documentation for compliance following regulation and guidance.
• Assure proper qualification of laboratory personnel according to regulatory standards.
• Perform regular internal quality audits in all laboratory sections; follow up with recommendations, corrective, and preventive actions as needed.
• Identify procedural and systemic compliance risks and recommend continuous improvements that complement existing practices.
• Review and follow up on non-conformances, deviations until resolution. Initiate corrective and preventative actions to address system deficiencies and drive implementation of corrective action plans.
• Oversee and manage quality system related meetings, collect and trend key performance indicators.
• Interface and collaborate with laboratory personnel to educate, provide training, and ensure compliance in all aspects of the clinical process.
• Lead and coordinate timely resolution of any audit findings.
• Lead and monitor deviations and corrective and preventative actions, ensuring a timely resolution and thorough documentation.
• Identify, assess, and manage quality risks or compliance concerns proactively and take immediate corrective action as required.
• Provide leadership and be a resource to staff regarding CLIA, CAP and related regulations and best practices, including maintaining knowledge of applicable regulations, providing consultation to staff regarding regulatory compliance.

Who You Are :