Manager, CE Quality & Regulatory Compliance

Endeavor Health•Skokie, IL

3d•$59 - $92

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. The 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 recall and hazard-alert programs, and medical-device cybersecurity programs. These programs are delivered through designated Clinical Engineer program leads. The Manager leads Clinical Engineers and the 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. The position includes full HR responsibilities for the team.

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.
Deep working knowledge of TJC, CMS Conditions of Participation, NFPA 99, and AEM frameworks.
Strong CMMS fluency for compliance reporting.
Excellent written communication skills and cross-functional coordination skills 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

Familiarity with medical-device cybersecurity standards and documentation, including FDA pre- and postmarket guidance, IEC 80001, and MDS2.
Experience with AEM risk scoring models.

Responsibilities

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