Manager, CE Quality & Regulatory Compliance

Nso 4901 Searle Parkway Corporate Office Skokiemid

Legal & ComplianceCompliance

0 views0 saves0 applied

Apply Now

Quick Summary

Key Responsibilities

Maintain continuous Joint Commission EC/EM, CMS Conditions of Participation, and NFPA 99 readiness; lead mock surveys, tracers, real-survey response,

Technical Tools

Legal & ComplianceCompliance

$59.05 - $91.53 - The hourly pay rate offered is determined by a candidate's expertise and years of experience, among other factors.

Position: Manager, Clinical Engineering Quality & Regulatory Compliance
Multiple Locations Available: Skokie, Corporate – Systemwide Coverage
Full Time/Part Time: Full time
Hours: Days; Regular hours of operation

Responsibilities

~2 min read

→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 Alternative Equipment Maintenance (AEM) program — 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 (FDA, ECRI, manufacturer) — direct the designated Clinical Engineer lead who executes intake, affected-asset identification via the CMMS, clinical notification, dispositioning, and closure documentation
→Own the medical-device cybersecurity program — accountable for CE's response to security incidents on connected devices, directing the designated Clinical Engineer lead and coordinating 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 — set program priorities, develop staff, manage performance, and integrate their work across the quality, regulatory, CMMS, and analytics programs; perform full HR responsibilities for the team
→Define regulatory KPIs and their targets — PM completion by risk class, overdue work orders, life-support compliance, recall closure, patch status; the CE Data Analyst builds and maintains the reporting infrastructure and data quality that monitor them
→Maintain CE compliance policies, procedures, and competency/training documentation; serve as CE liaison to Accreditation, Safety/EOC committees, and Infection Prevention

→Education:
- →Required: Bachelor's degree in clinical/biomedical engineering, healthcare administration, or a related field.
→Experience:
- →Required: 5+ years in HTM with demonstrated regulatory/accreditation and recall-management experience; working exposure to medical-device cybersecurity (incident response, vulnerability and patch management). 2+ years leading staff or programs.
→Unique or Preferred Skills:
- →Knowledge: Deep working knowledge of TJC, CMS Conditions of Participation, NFPA 99, and AEM frameworks; familiarity with medical-device cybersecurity standards (FDA pre/postmarket guidance, IEC 80001, MDS2).
- →Skills: Strong CMMS fluency for compliance reporting; excellent written communication; cross-functional coordination across Accreditation, Safety/EOC, Information Security, and clinical teams.
- →Abilities: Able to maintain continuous survey readiness; able to translate regulatory and cybersecurity requirements into actionable program controls and KPIs.
→Technical:
- →CMMS compliance reporting
- →AEM risk scoring models
- →MDS2/Medical device cybersecurity documentation

What We Offer

~2 min read

✓Opportunity for annual increases based on performance

✓Career Pathways to Promote Professional Growth and Development

✓Various Medical, Dental, Pet and Vision options

✓Tuition Reimbursement

✓Free Parking

✓Wellness Program Savings Plan

✓Health Savings Account Options

✓Retirement Options with Company Match

✓Paid Time Off and Holiday Pay

✓Community Involvement Opportunities

Location & Eligibility

Where is the job

Nso 4901 Searle Parkway Corporate Office Skokie

On-site at the office

Who can apply

Same as job location

About this job

Pay per year: ≈ $122,824–$190,382 a year; 32% above the $119,075 median for Compliance jobs on Jobera (619 salaries).
Posted: Today
Employer: has 1,836 open jobs on Jobera.