Regulatory Compliance Lead — Audit & CAPA Expert

The Donor Network Inc; Las Vegas (NV); On-site; USD 70,000 - 100,000; Full time

Job summary

Nevada Donor Network is seeking a Regulatory Compliance Coordinator in Las Vegas to monitor and analyze regulatory changes, lead internal audits, and support CAPA programs. You will work with the DQRA/MQRA to ensure compliance with state, federal, and accrediting agency standards and maintain SOP alignment.

Responsibilities include facilitating audits, developing audit schedules, and ensuring timely CAPA responses while supporting validation activities for equipment and software.

Qualifications

• Bachelor's degree in physical sciences or quality studies is required.
• Four to six years of auditing experience in regulated or certified industry.
• Experience working with an Organ Procurement Organization or Tissue Recovery/Processing facility is preferred.
• Microsoft office suite. Knowledge of Q-pulse or other quality management software preferred.
• ASQ certification preferred; years of experience may be considered in lieu of certification. Certification must be obtained within 18 months of employment.

Responsibilities

• Conduct internal audits per the established audit schedule to ensure compliance with state, federal, and accrediting agency regulations and standards and NDN SOPs, and assist with external audits.
• Assist the DQRA and MQRA with developing an annual audit schedule.
• Conduct audits in accordance with SOPs, including documentation in the quality management software audit program and initiating occurrence reports for audit findings.
• Serve as a resource for development of corrective actions to address observations and findings.
• Assist with preparation for and facilitation of external audits; develop regulatory and accrediting gap assessment tools.
• Monitor and analyze changes in legislation and accreditation standards affecting operations.
• Monitor vendor/supplier qualifications and maintain the supplier program in the quality management software.
• Maintain licensure or registrations and assist with new applications for licensure/registration.
• Track and trend audit findings and initiate improvement initiatives (OFIs).
• Assist with validation activities for equipment and software; ensure validation protocols and reports are completed.

Skills

Auditing

Regulatory compliance

Detail oriented

Communication

Teamwork

Education

Bachelor's degree in physical sciences or quality studies

ASQ certification preferred

Tools

Microsoft Office

Q-Pulse / Quality Management Software

Job description

Nevada Donor Network is seeking a Regulatory Compliance Coordinator in Las Vegas to monitor and analyze regulatory changes, lead internal audits, and support CAPA programs. You will work with the DQRA/MQRA to ensure compliance with state, federal, and accrediting agency standards and maintain SOP alignment.

Responsibilities include facilitating audits, developing audit schedules, and ensuring timely CAPA responses while supporting validation activities for equipment and software.