Laboratory Quality & Regulatory Leader

HNL Lab Medicine; Roble (CA); On-site; USD 90,000 - 120,000; Full time

Job summary

HNL Lab Medicine is seeking a Quality & Regulatory Specialist to support quality management and regulatory activities across the laboratory environment. You will drive a CLIA/ISO-aligned QMS, lead CAPA and RCA efforts, and coordinate with regulatory agencies to ensure inspections and accreditation status are maintained.

The role requires a Bachelor’s in a health care-related field (MT/MLS preferred) and 5+ years in lab operations with regulatory experience.

Qualifications

• Bachelor’s degree in a health care-related field; MT/MLS preferred.
• Minimum 5 years’ laboratory operations experience with quality/regulatory focus.
• Experience with accreditation/regulatory standards (CAP, TJC, DOH, FDA, CMS, ISO).
• Strong written and oral communication; cross‑department collaboration.
• Quality certifications (ASQ/NAHQ/ISO) preferred.

Responsibilities

• Develop, implement, and maintain a CLIA/ISO-aligned QMS.
• Track quality metrics to meet regulatory standards.
• Lead root cause analysis and CAPA activities.
• Serve as primary liaison for regulatory agencies; manage inspections.
• Coordinate internal quality and safety inspections across labs.
• Maintain document control and policy revisions.
• Prepare annual accreditation and safety reports.
• Guide regulatory content and approval workflows.
• Support risk management and discovery document gathering.

Skills

Quality management

Regulatory compliance

CAPA

Root Cause Analysis

PDSA cycle

Data-driven decisions

Interprofessional collaboration

Documentation and records

Analytical thinking

Cross-department liaison

Education

Bachelor’s degree in healthcare/related field

MT/MLS degree preferred

Tools

Laboratory Information System

Microsoft Office

Job description

HNL Lab Medicine is seeking a Quality & Regulatory Specialist to support quality management and regulatory activities across the laboratory environment. You will drive a CLIA/ISO-aligned QMS, lead CAPA and RCA efforts, and coordinate with regulatory agencies to ensure inspections and accreditation status are maintained.

The role requires a Bachelor’s in a health care-related field (MT/MLS preferred) and 5+ years in lab operations with regulatory experience.