Manager, CE Quality & Regulatory Compliance

Endeavor Health•Skokie, IL

About The Position

The Manager, Clinical Engineering Quality & Regulatory Compliance is the system-level owner of Endeavor Health’s Clinical Engineering quality and regulatory program across all nine hospitals. This role is accountable for the Medical Equipment Management Plan (MEMP), ongoing Joint Commission, CMS, and NFPA 99 readiness, the Alternative Equipment Maintenance (AEM) program, medical-device recalls and hazard alerts, and medical-device cybersecurity. Program delivery is carried out through designated Clinical Engineer leads. The manager leads Clinical Engineers and a CE Data Analyst, setting priorities, developing staff, managing performance, and integrating work across quality, regulatory, CMMS, and analytics programs. The role partners with Information Security, Supply Chain, clinical leadership, Accreditation, Safety/EOC committees, and Infection Prevention to keep the medical-device fleet safe, compliant, and survey-ready. It also has full HR responsibilities for the team. This full-time position is available in Skokie or Corporate, with systemwide coverage. The schedule is days during regular hours of operation. Applications are limited to current Sodexo and Trimedx employees. The stated hourly pay range is $59.05–$91.53, with the offered rate determined in part by expertise and years of experience. The application deadline is the end of day Wednesday, November 11th.

Requirements

Bachelor’s degree in clinical/biomedical engineering, healthcare administration, or a related field.
At least 5 years of experience in HTM with demonstrated regulatory/accreditation and recall-management experience.
Working exposure to medical-device cybersecurity, including incident response and vulnerability and patch management.
At least 2 years leading staff or programs.
Strong CMMS fluency for compliance reporting.
Excellent written communication.
Ability to coordinate across Accreditation, Safety/EOC, Information Security, and clinical teams.
Ability to maintain continuous survey readiness and translate regulatory and cybersecurity requirements into actionable program controls and KPIs.

Nice To Haves

Deep working knowledge of TJC, CMS Conditions of Participation, NFPA 99, and AEM frameworks.
Familiarity with medical-device cybersecurity standards and guidance, including FDA premarket and postmarket guidance, IEC 80001, and MDS2.
Experience with AEM risk-scoring models and medical-device cybersecurity documentation.

Responsibilities

Maintain continuous Joint Commission EC/EM, CMS Conditions of Participation, and NFPA 99 readiness; lead mock surveys, tracers, real-survey response, and Plan for Improvement (PFI) remediation.
Govern the Alternative Equipment Maintenance (AEM) program, including inclusion criteria, risk scoring, exclusion of high-risk and life-support equipment, and annual evaluation; ensure 100% preventive maintenance completion on high-risk and life-support devices.
Own the medical-device recall and hazard-alert program for FDA, ECRI, and manufacturer notices; direct the designated Clinical Engineer lead in intake, affected-asset identification through the CMMS, clinical notification, disposition, and closure documentation.
Own the medical-device cybersecurity program and CE’s response to security incidents on connected devices; direct the designated Clinical Engineer lead and coordinate containment and remediation with Information Security.
Oversee medical-device vulnerability and patch tracking and MDS2 review during procurement.
Own and annually update the system Medical Equipment Management Plan (MEMP); ensure each site’s program conforms and is audit-ready.
Lead Clinical Engineers and the CE Data Analyst by setting program priorities, developing staff, managing performance, integrating work across quality, regulatory, CMMS, and analytics programs, and performing full HR responsibilities.
Define regulatory KPIs and targets, including PM completion by risk class, overdue work orders, life-support compliance, recall closure, and patch status; oversee the CE Data Analyst’s reporting infrastructure and data quality.
Maintain Clinical Engineering compliance policies, procedures, and competency and training documentation.
Serve as the Clinical Engineering liaison to Accreditation, Safety/EOC committees, and Infection Prevention.