Specialist, Quality Assurance (Regulatory)

Join ExamOne (a Quest Diagnostics Company) as a Regulatory/Quality Specialist and play a critical role in advancing better health outcomes through dedicated regulatory and quality oversight. In this hybrid position based out of our Lenexa, KS office, your expertise will be key in ensuring our operations strictly adhere to company policies, as well as state, federal, and lab testing regulations, with a paramount focus on safeguarding PHI, PII, and patient confidentiality. A critical component of this position involves collaborating closely with key stakeholders across the business, internal compliance, privacy, and regulatory teams, as well as state and federal agencies to ensure seamless alignment and maintain the highest standards of operation.

This is a Hybrid position (3 days Onsite, 2 days WFH)

Licensing, Accreditation, and Permitting

• Assist with research, review, and re-verification for applicable federal, state, and county regulations.
• Coordinate the process to obtain necessary permits in support of collections and events.
• Ensure licensure is up to date and appropriate to the type of collections and events conducted.
• Collaborate with Quest Medical Directors and Quest laboratories to ensure compliance requirements are met.
• Ensure that the Company's business responsibilities and obligations are properly managed and compliant by conducting audits on client accounts with access to data products.
• Ensure compliance with HIPAA (Health Insurance Portability and Accountability Act) by auditing customer authorization forms
• Support the internal inspection process of the business unit to ensure compliance with applicable federal, state, and local regulations and Quest Diagnostics standards.

Auditing

Quality Assurance

• Maintenance of records required for certifications/inspections and compliance with all procedures, regulations and policies.
• Ensures compliance with all applicable regulatory agencies through documentation, audits and corrective action.
• Review and address issues around protected health information (PHI) investigations and reportable quality issues, ensuring that responses are accurate and complete as well as ensuring that immediate, short-term and long-term corrective actions are implemented.
• Performs special projects as assigned.

Required WorkExperience:

• At least three years employment in a laboratory or healthcare setting required
• Experience with Quality Assurance and laboratory or healthcare regulations/accreditation requirementsrequired.

Preferred Work Experience:

• Experience with HIPAA privacy regulations preferred.
• Experience with Regulatory Audit process and documentation preferred.

Skills:

• Strong interpersonal communication skillsrequired
• Demonstrated strong writing and composition skillsrequired
• Understands clinical laboratory operationsrequired
• Able to effect Quality Improvement through problem solving skills and knowledge of quality tools required
• Able to manage changerequired Organization skillsrequired Project management skills required
• Analytical skills required
• Technical skills required
• Computer skills required
• Able to function in a matrix organization desirable
• Multi-tasking skills desirable
• Demonstrated success in motivating team members to reach objectivesdesirable

Education

• Bachelor's Degree (Required)

Licenses and Certifications

Certifications Qualification as General Laboratory Supervisor as defined by CLIA '88 (Required)