Systemwide Clinical Engineering: Quality & Regulatory Lead

NorthShore University HealthSystem; Skokie (IL); Sur place; USD 81 000 - 126 000; Plein temps

Avantages offerts par ce poste

Health benefits

Paid time off

Tuition reimbursement

Résumé du poste

Endeavor Health is seeking a Manager, Clinical Engineering Quality & Regulatory Compliance to oversee the enterprise-wide regulatory and quality program for nine hospitals. You will lead a team of Clinical Engineers and a CE Data Analyst, partner with Information Security and Supply Chain, and ensure survey readiness, device safety, and compliant operations across the system.

You will drive KPIs, update the MEMP, manage recalls and cybersecurity, and translate regulations into actionable program

Qualifications

• Bachelor's degree required in clinical/biomedical engineering, healthcare administration, or related field.
• 5+ years HTM with regulatory/accreditation and recall-management experience; 2+ years leading staff or programs.
• Deep working knowledge of TJC, CMS COPs, NFPA 99, and AEM frameworks; familiarity with medical-device cybersecurity standards.

Responsabilités

• Maintain Joint Commission EC/EM, CMS COPs readiness; lead mock surveys and remediation.
• Govern the AEM program including risk scoring and ensuring PM completion on high-risk devices.
• Own medical-device recall and hazard-alert program with proper dispositioning and closure documentation.
• Own medical-device cybersecurity program and coordinate with Information Security; oversee patch tracking and MDS2 review.
• Update and audit the system Medical Equipment Management Plan (MEMP) across sites.
• Lead CE team and CE Data Analyst; perform HR responsibilities and develop staff.
• Define regulatory KPIs and targets; data analyst maintains reporting infrastructure.

Connaissances

Written communication

Cross-functional coordination

Regulatory knowledge

Formation

Bachelor's degree in clinical/biomedical engineering or related field

Outils

CMMS

MDS2

AEM

Description du poste

Endeavor Health is seeking a Manager, Clinical Engineering Quality & Regulatory Compliance to oversee the enterprise-wide regulatory and quality program for nine hospitals. You will lead a team of Clinical Engineers and a CE Data Analyst, partner with Information Security and Supply Chain, and ensure survey readiness, device safety, and compliant operations across the system.

You will drive KPIs, update the MEMP, manage recalls and cybersecurity, and translate regulations into actionable program