Lab Quality & Compliance Specialist

Health Network Laboratories, LLC; Allentown (Lehigh County); On-site; USD 90,000 - 120,000; Full time

Job summary

Health Network Laboratories, LLC seeks a Quality & Regulatory Specialist to support the laboratory's quality management program and regulatory compliance. Responsibilities include developing a CLIA/ISO-aligned QMS, coordinating CAP/DOH/OSHA/CMS surveys, and driving CAPA actions through data-driven improvement initiatives across acute care laboratories.

The role emphasizes collaboration with management, document control, risk assessments, and training to ensure ongoing accreditation and safe,

Qualifications

• Bachelor’s degree in a health care-related field or equivalent scientific field.
• MT/MLS degree preferred.
• Minimum of 5 years’ experience in laboratory operations.
• Experience overseeing quality/regulatory functions or 2-3 years of experience working in an environment in accordance with accreditation/regulatory/safety standards (e.g., CAP, TJC, DOH, AABB, FDA, CMS, ISO).
• Certification by recognized certifying agency for quality professionals preferred (ASQ, NAHQ, ISO).

Responsibilities

• Develop, implement, and maintain a comprehensive quality management system (QMS) aligned with relevant accreditation standards (e.g., CLIA, ISO).
• Collaborate with laboratory management to develop, implement, and track key quality metrics to meet regulatory standards.
• Analyze and identify trends in statistical quality data; implement improvement actions; generate reports on quality activities.
• Serve as the primary point of contact for external regulatory agencies and manage inspections/surveys (CAP, DOH, OSHA, CMS, TJC).
• Coordinate internal quality and safety inspections and maintain document control for policies and approvals.

Education

Bachelor’s degree in health care-related field or equivalent scientific field

MT/MLS degree preferred

Job description

Health Network Laboratories, LLC seeks a Quality & Regulatory Specialist to support the laboratory's quality management program and regulatory compliance. Responsibilities include developing a CLIA/ISO-aligned QMS, coordinating CAP/DOH/OSHA/CMS surveys, and driving CAPA actions through data-driven improvement initiatives across acute care laboratories.

The role emphasizes collaboration with management, document control, risk assessments, and training to ensure ongoing accreditation and safe,