Laboratory Quality Manager

Lighthouse Lab Services•Schaumburg, IL

About The Position

Lighthouse Lab Services is partnering with a growing diagnostic laboratory near Chicago, IL to recruit a Lab Quality Manager. This critical role reports directly to the Director of Regulatory and Quality Affairs and is responsible for leading the laboratory’s Quality Management Program in alignment with CLIA, CAP, NYS, and the companies quality standards. This is an excellent opportunity for an experienced quality professional who thrives in a regulated, fast-paced clinical lab environment and is passionate about maintaining audit readiness, continuous improvement, and regulatory compliance.

Requirements

Bachelor of Science in Medical Technology, Laboratory Sciences, or a related scientific discipline.
Minimum 8 years of experience in a high-complexity CLIA-certified clinical laboratory.
Deep understanding of regulatory standards (CLIA, CAP, NYS).
Strong organizational, documentation, and written communication skills.
Experience in quality systems, audit preparation, and cross-functional team leadership.
Ability to assess risk and drive corrective/preventive actions.
Excellent judgment, attention to detail, and collaboration skills in a regulated environment.

Responsibilities

Ensure continued laboratory licensure and accreditation (CLIA, CAP, NYS) by managing renewals, new applications, test method submissions, and proficiency testing programs.
Serve as the primary liaison between the lab and accrediting/regulatory agencies.
Administer the lab’s document control system, incident reporting, and personnel documentation processes.
Review all laboratory SOPs and validation materials for regulatory compliance.
Ensure staff qualifications align with regulatory requirements.
Conduct internal quality audits across all lab sections and lead follow-up actions including CAPAs.
Proactively identify compliance risks and recommend system improvements.
Lead investigations and resolutions of non-conformances and deviations.
Organize and lead quality system meetings; track and trend key performance indicators (KPIs).
Train and support lab personnel in quality practices and regulatory standards.
Manage audit response activities and ensure timely, well-documented resolutions.
Provide regulatory and quality leadership across teams, staying current with evolving requirements.