Quality & Regulatory Lead: Lab Compliance & Audits

Health Network Laboratories LLC; United States; On-site; USD 85,000 - 115,000; Full time

Job summary

Health Network Laboratories LLC seeks a Quality & Regulatory Specialist to support the quality management program and regulatory standards within a clinical laboratory environment. You will develop and maintain a QMS, monitor metrics, and coordinate external inspections to ensure accreditation and compliance with CAP, DOH, OSHA, CMS, and TJC.

You will lead document control, CAPA investigations, risk assessments, and training initiatives, fostering a culture of quality, safety, and continuous

Qualifications

• Bachelor’s degree in a health care-related field; MT/MLS preferred.
• Minimum of 5 years’ experience in laboratory operations.
• Experience overseeing quality/regulatory functions or 2–3 years in accreditation/regulatory/safety standards (CAP, TJC, DOH, FDA, CMS, ISO).
• Certification by a recognized certifying body for quality professionals preferred (ASQ, NAHQ, ISO).
• Strong analytical, problem-solving and cross-department collaboration skills.

Responsibilities

• Develop, implement, and maintain a comprehensive QMS aligned with accreditation standards (e.g., CLIA, ISO).
• Collaborate with management to develop, implement, and track quality metrics to meet regulatory standards.
• Coordinate external inspections/audits (CAP, DOH, OSHA, CMS, TJC, etc.).
• Maintain document control system and ensure document integrity.
• Identify, document, and investigate non-conforming events; implement CAPA.
• Support risk management and legal for discovery; perform RCA and RA.
• Provide training materials and oversee quality/safety topics.
• Promote culture of quality, safety, and continuous improvement across departments.

Skills

Quality management

Regulatory knowledge

Data analysis

CAP/DOH/CMS experience

Documentation control

Audit coordination

Risk assessment

CAPA

Education

Bachelor’s degree

MT/MLS degree preferred

Tools

LIS

Microsoft Office

Job description

Health Network Laboratories LLC seeks a Quality & Regulatory Specialist to support the quality management program and regulatory standards within a clinical laboratory environment. You will develop and maintain a QMS, monitor metrics, and coordinate external inspections to ensure accreditation and compliance with CAP, DOH, OSHA, CMS, and TJC.

You will lead document control, CAPA investigations, risk assessments, and training initiatives, fostering a culture of quality, safety, and continuous