Quality and Regulatory Specialist

HNL Lab Medicine•Durham, CA

1d•Onsite

About The Position

The Quality and Regulatory Specialist supports HNL’s quality and regulatory functions in accordance with its quality management program and applicable policies. The role provides subject matter expertise concerning OSHA, DOH, CMS, CAP, and other accrediting-body and regulatory standards applicable to the laboratory environment. The specialist develops and maintains the quality management system, tracks quality metrics, analyzes statistical quality data, and coordinates improvement actions and reporting. The role serves as the primary contact for external regulatory agencies and manages certifications and licenses. It also prepares for external inspections and surveys, coordinates internal quality and safety inspections, and supports corrective and preventive actions. Responsibilities include maintaining document control, investigating nonconforming events and patient safety events, supporting risk assessments and root cause analyses, preparing quality and safety meetings and reports, and developing training materials and policies. The specialist supports daily operations and the manager as needed, promotes customer satisfaction, and fosters a culture of quality, safety, data-driven decision-making, and continuous improvement. This position is onsite at HNL- Roble.

Requirements

Bachelor’s degree from an accredited program in a healthcare-related or equivalent scientific field.
Experience overseeing quality or regulatory functions, or 2–3 years of experience working in an environment governed by accreditation, regulatory, or safety standards such as CAP, TJC, DOH, AABB, FDA, CMS, or ISO.
Ability to read, analyze, and interpret scientific and technical journals, financial reports, and legal documents.
Ability to respond to inquiries or complaints from customers, regulatory agencies, and members of the business community; write speeches and articles in a prescribed style and format; and collaborate effectively across departments.
Ability to apply mathematical concepts, including probability, statistical inference, percentages, ratios, and proportions, and to compute and interpret averages, medians, means, charts, and graphs.
Ability to define problems, collect data, establish facts, draw valid conclusions, interpret technical instructions, and manage variables.
Ability to resolve conflicts between departments while minimizing disruption to laboratory operations.
Strong problem-solving skills and ability to make data-driven decisions and resolve issues affecting laboratory performance, quality, and safety.
Ability to use Microsoft Office products and other software, including a Laboratory Information System.

Nice To Haves

MT/MLS degree preferred.
At least 5 years of experience working in laboratory operations preferred.
Certification from a recognized certifying agency for quality professionals, such as ASQ, NAHQ, or ISO, preferred.

Responsibilities

Develop, implement, and maintain a quality management system aligned with applicable accreditation standards, including CLIA and ISO.
Collaborate with laboratory management to develop, implement, and track quality metrics aligned with laboratory goals and regulatory standards.
Analyze statistical quality data and trends, collaborate on improvement actions, and generate reports on quality activities and outcomes.
Serve as the primary point of contact for external regulatory agencies; respond to inquiries and compliance issues and manage certifications and licenses.
Coordinate and support external inspections and surveys, prepare the laboratory for audits, address identified gaps, and assist with resolving findings and implementing corrective and preventive actions.
Plan and conduct internal quality and safety inspections of laboratory departments and Acute Care Laboratories as assigned; analyze findings and coordinate corrective and preventive actions.
Implement and maintain document control, including developing and revising policies to meet regulatory and accreditation requirements.
Guide policy owners and technical subject matter experts on document content, formatting, and approval workflows.
Identify, document, and investigate nonconforming events, patient safety events, and client feedback using event reporting systems; support timely resolution and effective corrective and preventive actions.
Generate reports communicating trends and outcomes of quality activities.
Support the Risk Manager and legal counsel with documents for discovery requests; conduct root cause analyses and risk assessments as needed while protecting confidential information.
Assist with preparation for quality and safety meetings, participate as assigned, represent the quality department on projects, and help prepare annual reports on accreditation, quality, and safety.
Support the manager in daily operations and assist with tasks as needed.
Develop training materials and programs, policies, and procedures concerning quality, safety, and regulatory requirements, and train laboratory staff.
Promote customer satisfaction and service excellence by meeting customers’ quality expectations.
Encourage data-driven decision-making and guide team members in applying the PDSA cycle and continuous-improvement methods.
Build effective working relationships with laboratory staff and clients, communicate and collaborate across disciplines, and provide guidance on technical, quality, and safety matters.