The CSPD & HLD Regulatory and Compliance Manager provides enterprise-wide leadership, governance, and strategic oversight for Central Sterile Processing (CSPD), High-Level Disinfection (HLD), Clinical Endoscope Reprocessing (CER), and Quality Management programs across the health system. Serving as the designated subject matter expert, this role is responsible for advancing best practices in sterilization, high-level disinfection, flexible endoscope reprocessing, regulatory compliance, accreditation readiness, and quality management. The Manager leads the development, implementation, and administration of a comprehensive enterprise Quality Management Program designed to enhance patient safety, ensure regulatory and accreditation compliance, drive operational excellence, and promote standardization across acute care facilities, ambulatory sites, procedural areas, and off-site locations. This position provides administrative and operational oversight for system-wide CSPD, HLD, and endoscope reprocessing and reprocessed medical device initiatives, ensuring adherence to manufacturer Instructions for Use (IFUs), applicable federal and state regulations, accreditation requirements, and evidence-based industry standards. The Manager is accountable for establishing performance measures, monitoring compliance, identifying risks, and implementing sustainable process improvements that support high-reliability healthcare operations. In partnership with Central Sterile Processing, Clinical Endoscope Reprocessing Departments (CERD), Infection Prevention, Surgical Services, Nursing, Facilities, Accreditation and Regulatory Affairs, Safety Management, Biomedical Engineering, Value Analysis, Supply Chain, and health system leadership, this role drives enterprise regulatory readiness, quality improvement initiatives, workforce education, risk reduction strategies, performance analytics, and long-range strategic planning to ensure the consistent delivery of safe, compliant, and high-quality patient care services.

Administrative Leadership & Program Management 

• Provide administrative leadership and operational oversight for enterprise CSPD and HLD regulatory, compliance, and quality programs. 
• Develop and execute strategic goals, objectives, and performance improvement initiatives aligned with organizational priorities. 
• Manage system-wide CSPD and HLD governance structures, committees, workgroups, and interdisciplinary partnerships. 
• Establish annual program goals, budgets, key performance indicators, and operational priorities. 
• Lead enterprise standardization efforts for policies, procedures, workflows, equipment utilization, and quality practices.
• CSPD & HLD Regulatory and Compliance Manager 
• Prepare and present reports, performance metrics, risk assessments, and regulatory updates to senior leadership and executive stakeholders. 
• Facilitate system-wide communication regarding regulatory changes, accreditation requirements, and emerging industry standards. 
• Support business planning, facility expansion, renovation, construction, and capital equipment initiatives related to reprocessing and sterilization operations. 
• Provide administrative oversight for consultants, vendors, contracts, and external regulatory engagements as appropriate. 
• Serve as the primary liaison between enterprise leadership and operational departments regarding CSPD and HLD compliance matters.

Regulatory Compliance & Accreditation 

• Serve as the health system expert in sterilization, high-level disinfection, flexible endoscope reprocessing, probes, instrument processing standards and other reusable medical devices that are processed in the enterprise. 
• Ensure compliance with requirements established by The Joint Commission, CDC, CMS, OSHA, FDA, AAMI, AORN, SGNA, and applicable state and federal regulations. 
• Maintain enterprise accreditation readiness through continuous monitoring, tracers, mock surveys, audits, and performance evaluations. 
• Lead regulatory investigations, corrective action planning, and risk mitigation activities related to CSPD and HLD operations. 
• Coordinate responses to accreditation surveys, regulatory inspections, and external agency requests. 
•  Develop and maintain enterprise CSPD and HLD policies, procedures, standards of practice, and governance documents. 
• Monitor evolving regulatory and industry requirements and implement changes across the health system. 
• Conduct compliance assessments and gap analyses to identify opportunities for improvement and standardization.
• Quality Management Program Leadership 
• Oversight of quality operations within CSPD departments across the enterprise. 
• Develop, implement, and oversee the Enterprise CSPD and HLD Quality Management Program. 
• Establish and monitor quality indicators, key performance metrics, compliance measures, and outcome dashboards. 
• Lead quality assurance and quality control processes related to sterilization, high-level disinfection, endoscope reprocessing, and instrument management. 
• Analyze and integrate trends from audit findings, non-conformances, near misses, adverse events, risk reports, and the internal Quality Assurance Tracker to identify systemic issues, uncover improvement opportunities, and drive continuous quality and patient safety enhancements. 
• Build out additional audit processes to help better assess performance and compliance across all sites. 
• Develop corrective and preventive action plans and ensure sustained compliance through ongoing monitoring.

CSPD & HLD Regulatory and Compliance Manager 

• Partner with site leaders, Infection Prevention, Quality and Patient Safety, Risk Management, and Accreditation teams to address quality concerns and regulatory risks. 
• Lead Root Cause Analyses (RCAs), Failure Mode and Effects Analyses (FMEAs), and other quality improvement methodologies. 
• Develop reporting structures and enterprise scorecards to measure program effectiveness and operational performance. 
• Promote a culture of quality, accountability, patient safety, and continuous improvement throughout the organization. 
• Coordination of education and corrective action plans, either directly or in partnership with site leaders.

Operational Excellence & Performance Improvement

• Collaborate with operational leaders to optimize workflows, staffing models, productivity, and resource utilization. 
• Lead initiatives focused on reducing variation and improving operational reliability across facilities. 
• Utilize Lean, Six Sigma, and other process improvement methodologies to enhance efficiency and performance. 
• Support implementation and optimization of sterilization and HLD technologies, equipment, and software solutions. 
• Monitor productivity, throughput, turnaround times, and operational benchmarks. 
• Drive enterprise standardization efforts related to reprocessing practices and inventory management. 
• Validate audit outcomes, assess educational effectiveness, and support enterprise initiatives as needed.

Education, Training & Competency Development 

• Develop, implement, and oversee enterprise education programs for CSPD, HLD, and endoscope reprocessing personnel. 
• Establish standardized onboarding, orientation, annual competency validation, and continuing education programs. 
• Ensure staff maintain regulatory-required competencies and certification requirements. 
• Facilitate leadership development, succession planning, and professional growth opportunities. 
• Partner with educators, Infection Prevention, Accreditation, and operational leaders to ensure alignment with industry standards and best practices. 
• Promote certification advancement and lifelong professional development among reprocessing personnel.

Collaboration & Stakeholder Engagement 

• Partners with CSPD, CERD, Nursing, Surgical Services, Infection Prevention, Accreditation, Facilities, Biomedical Engineering, Value Analysis, Occupational Safety, and Health System leadership as necessary. 
• Partnership with IP and Accreditation teams during site visits and collaborative reviews of CSPD and HLD practices across the enterprise and regional as necessary. 
• Co-chair committees and facilitate interdisciplinary collaboration to support enterprise initiatives.

CSPD & HLD Regulatory and Compliance Manager 

• Serve as a consultant and advisor regarding sterile processing, endoscope reprocessing, and high-level disinfection operations. 
• Participate in planning, design, construction, and renovation projects involving CSPD and HLD environments. 
• Build strong collaborative relationships that drive accountability, compliance, and operational excellence. 
• Provide enterprise support and cross-coverage for regional locations, including Sparrow Health System and UM Health-West. 
• Review, approve, and maintain policies, procedures, and standards related to HLD and sterilization practices. 
• Lead special projects and strategic initiatives supporting organizational goals.

Education

• Bachelor's degree in healthcare administration, business administration or applicable field, or equivalent combination of related education and experience is required.

Certifications

• Certified Registered Central Service Technician (CRCST) or Certified Sterile Processing and Distribution Technician (CSPDT) certification required upon hire and maintained throughout duration of employment. 
• Certified Endoscope Reprocessor (CER) or Certified Flexible Endoscope Reprocessor (CFER) certification required upon hire and maintained throughout duration of employment.

Experience

• Minimum of three years of progressively responsible experience in sterile processing, endoscope reprocessing, high-level disinfection, healthcare quality, regulatory compliance, or related healthcare operations. 
• Minimum of three years of leadership, management, accreditation, quality, compliance, or program administration experience. 
• Experience leading enterprise quality, regulatory, accreditation, or patient safety initiatives. 
• Experience working within a large academic medical center or complex multi-site healthcare system.

Knowledge, Skills, and Abilities 

• Demonstrated expertise in sterilization, high-level disinfection, instrument processing, and flexible endoscope reprocessing. 
• Advanced knowledge of sterilization, high-level disinfection, flexible endoscope reprocessing, and instrument processing standards. 
• Expert understanding of AAMI, AORN, CDC, FDA, CMS, OSHA, SGNA, Joint Commission, and applicable regulatory requirements.
• CSPD & HLD Regulatory and Compliance Manager  Strong leadership, organizational, project management, and strategic planning skills. 
• Ability to analyze complex operational and regulatory issues and develop effective solutions. 
• Experience designing and managing quality management systems and enterprise compliance programs. 
• Strong presentation, communication, facilitation, and stakeholder engagement skills. 
• Ability to influence decision-making and drive system-wide change initiatives. 
• Demonstrated success in standardization, operational improvement, and change management. 
• Proficiency with Microsoft Office Suite, data analytics platforms, quality reporting systems, and healthcare information systems. 
• Ability to coordinate activities across multiple hospitals, ambulatory sites, and procedural locations. 
• Demonstrated commitment to patient safety, quality, regulatory compliance, and continuous improvement. 
• Effective verbal and written communication skills. 
• Ability to meet Michigan Medicine customer service standards. 
• Creative, analytical, independent, and self-directed.

Certifications:  Additional HSPA and/or CBSPD certifications.

Experience:  Experience leading Lean, Six Sigma, or other operational excellence initiatives.

Primarily day shift; must be available to flex across all shifts including weekends, afternoons and nights as needed. 

Must have reliable transportation to commute to various sites across the state.

Additional Information Reports to Senior Director for Enterprise Disinfection & Sterilization Services. This description is intended to indicate the kinds of tasks and levels of work difficulty that will be required of positions that will be given this title and shall not be construed as declaring what the specific duties and responsibilities of any particular position shall be. It is not intended to limit or in any way modify the right of any supervisor to assign, direct, and control the work of employees under this supervision. The use of a particular expression or illustration describing duties shall not be held to exclude other duties not mentioned that are of a similar kind or level of difficulty.

Michigan Medicine conducts background screening and pre-employment drug testing on job candidates upon acceptance of a contingent job offer and may use a third party administrator to conduct background screenings.  Background screenings are performed in compliance with the Fair Credit Report Act. Pre-employment drug testing applies to all selected candidates, including new or additional faculty and staff appointments, as well as transfers from other U-M campuses.

Job openings are posted for a minimum of seven calendar days. This job may be removed from posting boards and filled anytime after the minimum posting period has ended.

The University of Michigan is an Equal Opportunity Employer. We are committed to providing an environment of mutual respect where equal employment opportunities are available to all applicants, including protected veterans and individuals with disabilities.