Quality & Regulatory Leader — Lab Compliance

HNL Lab Medicine; Durham (CA); On-site; USD 70,000 - 90,000; Full time

Job summary

HNL Lab Medicine is seeking a Quality & Regulatory Specialist to support quality and regulatory functions within the laboratory environment. This role provides subject matter expertise on OSHA, DOH, CMS, CAP, and other accrediting bodies, ensuring accreditation and regulatory standing are maintained.

The position involves coordinating internal and external inspections, maintaining document control, and guiding policy owners on document content and approval workflows to uphold quality standards.

Qualifications

• Bachelor's degree or equivalent in a health care-related field required; MT/MLS preferred.
• Minimum of 5 years' experience in laboratory operations preferred; regulatory/safety standards experience highly valued.
• Certification in quality (ASQ/NAHQ/ISO) preferred.

Responsibilities

• Develop, implement, and maintain a comprehensive quality management system (QMS) aligned with accreditation standards (CLIA, ISO).
• Collaborate to develop and track key quality metrics and ensure compliance with regulatory standards.
• Analyze quality data, identify trends, and implement corrective actions with CAPA reporting.

Skills

Quality management

Regulatory compliance

CAP/TJC knowledge

Documentation control

Data analysis

Education

Bachelor's degree in health care-related field

MT/MLS preferred

Tools

LIS

Microsoft Office

Job description

HNL Lab Medicine is seeking a Quality & Regulatory Specialist to support quality and regulatory functions within the laboratory environment. This role provides subject matter expertise on OSHA, DOH, CMS, CAP, and other accrediting bodies, ensuring accreditation and regulatory standing are maintained.

The position involves coordinating internal and external inspections, maintaining document control, and guiding policy owners on document content and approval workflows to uphold quality standards.