Risk and Quality Compliance Manager (RN)

The Risk and Quality Compliance Manager is responsible for identifying and coordinating clinical risk management activities, supporting quality improvement efforts, and ensuring compliance with regulatory standards. This role includes conducting root cause analyses, analyzing patient data, and collaborating with departments on performance improvement initiatives to prevent harm. The manager plays a key role in promoting high-quality patient care, safety, and operational efficiency through effective risk management and quality assurance practices. They also serve as a resource and advocate for safe clinical practices, working closely with leadership, frontline staff, and quality teams to implement evidence-based strategies.

The position requires clinical experience and in-depth knowledge of regulatory and accreditation requirements, including those from the Illinois Department of Public Health (IDPH), The Joint Commission (TJC), Centers for Medicare & Medicaid Services (CMS), Illinois Statutes, and Occupational Safety and Health Administration (OSHA). The manager also plays a crucial role in fostering a culture of safety, ensuring regulatory compliance, and enhancing patient quality and safety through data-driven analysis and collaboration.

Required Education:

• Bachelor’s degree in Nursing (BSN) or other clinical healthcare field
• Current Registered Nurse (RN) license in the State of Illinois

Desirable Education:

• Master’s degree in Nursing, Healthcare Administration, Public Health, or related field
• Certified Professional in Healthcare Risk Management (CPHRM)
• Certification in Quality Improvement (CPHQ)
• Just Culture Certified
• OSHA training and /or certification within 1 year of hire

Required Experience:

• Minimum 3 years of recent clinical experience in an acute care hospital setting
• Minimum 2 years of experience in healthcare risk management, quality improvement: leading or facilitating root cause analyses.
• Experience interpreting, applying, and interacting with IDPH, TJC, CMS, Illinois statutes, and OSHA regulations in collaboration with healthcare teams to ensure regulatory compliance and promote patient safety.

Desirable Experience:

• Requires a minimum of three (3) years of experience interpreting and applying Joint Commission (TJC) regulations, with proficiency in Periodic Performance Review (PPR) processes and TJC AMP software.

Responsibilities

• Develop, implement, and monitor comprehensive risk management and quality compliance programs aligned with industry standards and regulatory requirements.
• Lead internal and external quality audits to evaluate compliance with ISO 13485, FDA regulations, HACCP, CGMP, ISO 9001, and other relevant standards.
• Oversee the design and continuous improvement of quality systems to enhance product safety, efficacy, and overall quality assurance.
• Collaborate with cross-functional teams to ensure manufacturing processes meet strict quality control and inspection protocols.
• Conduct detailed analysis of quality data to identify trends, root causes of issues, and opportunities for process enhancements.
• Provide training and guidance on quality management principles to staff across departments.
• Manage documentation related to compliance activities, audit reports, corrective actions, and regulatory submissions.

Skills

• Extensive knowledge of ISO 13485 standards for medical devices as well as FDA regulations governing healthcare manufacturing.
• Strong understanding of HACCP principles, CGMP practices, ISO 9001 standards, and quality audit procedures.
• Proven experience in manufacturing environments with a focus on quality control and assurance processes.
• Excellent analysis skills capable of interpreting complex data sets to inform decision-making.
• Project management expertise to coordinate multiple initiatives simultaneously while maintaining compliance deadlines.
• Effective communication skills for training teams and liaising with regulatory agencies.
• Demonstrated leadership in developing or improving quality systems within regulated industries. This position offers an opportunity for a dedicated professional to influence the safety and reliability of healthcare products through rigorous risk management and compliance excellence.

A Roman Catholic facility founded by the Religious Hospitallers of St. Joseph and sponsored by Catholic Health International, St. Bernard Hospital aspires to live in the healing mission of Christ within the South Side community of Chicago. This mission calls us to care for the sick and promote the health of the residents in the community while witnessing the Christian values of respect, dignity, caring and compassion for all persons. In all matters, St. Bernard Hospital will show a special sensitivity to the culture of the people we serve and the unique needs of the poor and powerless.