Director of Quality

Director of Quality

Donor Services Laboratory (DSL)

ONSITE — Las Vegas, Nevada

About Donor Services Laboratory

Donor Services Laboratory (DSL) provides specialized laboratory testing to support the donation and transplant industry.

Position Overview

DSL is seeking a Director of Quality to lead its Quality Management System (QMS), oversee regulatory compliance and accreditation, and drive continuous improvement. This role partners with executive leadership, Medical Directors, and laboratory operations to maintain inspection readiness, strengthen quality systems, and promote a culture of quality and accountability.

Key Responsibilities

• Lead and maintain the Quality Management System to ensure regulatory and accreditation compliance.

• Oversee audits, inspections, quality investigations, root cause analysis, and corrective and preventive actions (CAPAs).

• Maintain quality policies, procedures, documentation, and training programs.

• Monitor quality metrics, identify risks, and drive continuous improvement.

• Lead and develop Quality personnel.
• Partner with executive leadership, Medical Directors, and laboratory operations to address compliance risks and improve processes.

Required Qualifications

• Bachelor's degree in laboratory science, life sciences, quality management, regulatory affairs, or a related field.

• At least 5 years of progressive experience in quality assurance, quality management, or regulatory compliance within a laboratory, healthcare, life sciences, or regulated environment.

• At least 3 years of experience leading or supervising personnel or quality functions.

• Experience managing quality systems, audits, investigations, root cause analysis, and CAPAs.

• Knowledge of applicable regulatory and accreditation requirements, including CLIA, FDA, CAP, and ISO standards.

Preferred Qualifications

• Experience in an FDA-regulated, CLIA-certified, CAP-accredited, ISO-certified, or HCT/P-related environment.

• Experience leading regulatory inspections and accreditation surveys.

• ASQ, regulatory affairs, or Six Sigma certification.

Work Authorization

• This is an onsite position in Las Vegas, Nevada. Candidates must be authorized to work in the United States without current or future employer-sponsored visa sponsorship.

• DSL is an equal opportunity employer and considers qualified applicants based on job-related qualifications and applicable law.