Laboratory Quality Manager

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 laboratorys 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.

Key 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 labs 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.

Qualifications:

• 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.

Salary and Benefits:

• Competitive salary
• Health Vision Dental
• PTO and Holidays
• Addtl misc. benefits

Must be a US citizen or eligible to work in the US for any employer. No sponsorship will be provided.

About Us:
At Lighthouse Lab Services we offer solutions to help start grow and run clinical laboratories. Our recruiting team has over 21 years of proven success placing job seekers in positions ranging from entry level Medical Technologists to seasoned Laboratory Directors. We recruit nationwide for permanent and travel positions with clients ranging from small hospitals to large reference laboratories.

It is the policy of Lighthouse Lab Services to provide equal employment opportunity (EEO) to all persons regardless of age color national origin citizenship status physical or mental disability race religion creed gender sex sexual orientation gender identity and/or expression genetic information marital status status with regard to public assistance veteran status or any other characteristic protected by federal state or local law. Lighthouse Lab Services is committed to working and providing reasonable accommodation to individuals of all abilities including persons with disabilities. If at any time during the application process you need an accommodation please contact for assistance.

Lighthouse Lab Services

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Required Experience:

Manager