Manager, CE Quality & Regulatory Compliance

NorthShore University HealthSystem; Skokie (IL); Vor Ort; USD 81.000 - 126.000; Vollzeit

Benefits dieser Stelle

Health benefits

Paid time off

Tuition reimbursement

Zusammenfassung

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

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Written communication

Cross-functional coordination

Regulatory knowledge

Ausbildung

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

Tools

CMMS

MDS2

AEM

Jobbeschreibung

Hourly Pay Range:

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

Position Highlights:

• 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

Job Summary:

System-level owner of Endeavor Health's Clinical Engineering quality and regulatory program across all nine hospitals. Accountable for the Medical Equipment Management Plan (MEMP); continuous Joint Commission, CMS, and NFPA 99 readiness; the Alternative Equipment Maintenance (AEM) program; medical-device recall; hazard-alert; and cybersecurity programs, delivered through designated Clinical Engineer program leads. Leads a team of Clinical Engineers and the CE Data Analyst. Partners with Information Security, Supply Chain, and clinical leadership to keep the medical-device fleet safe, compliant, and survey-ready.

What you will do:

• 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

What you will need:

• 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

Benefits (For full time or part time positions):

• 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

Endeavor Health is a fully integrated healthcare delivery system committed to providing access to quality, vibrant, community-connected care, serving an area of more than 4.2 million residents across six northeast Illinois counties. Our more than 25,000 team members and more than 6,000 physicians aim to deliver transformative patient experiences and expert care close to home across more than 300 ambulatory locations and eight acute care hospitals - Edward (Naperville), Elmhurst, Evanston, Glenbrook (Glenview), Highland Park, Northwest Community (Arlington Heights) Skokie and Swedish (Chicago) - all recognized as Magnet hospitals for nursing excellence. For more information, visit www.endeavorhealth.org.

When you work for Endeavor Health, you will be part of an organization that encourages its employees to achieve career goals and maximize their professional potential.

Please explore our website www.endeavorhealth.org to better understand how Endeavor Health delivers on its mission to "help everyone in our communities be their best".

Endeavor Health is committed to working with and providing reasonable accommodation to individuals with disabilities. Please refer to the main career page for more information.

At Endeavor Health, we are united by a shared commitment to working together to create a culture of connection and belonging-each of us bringing different skills and experiences as we deliver safe, seamless, and personal care. Every person, every time. We are committed to fostering an environment where all team members can be their best, learn, and pursue excellence together.

EOE: Race/Color/Sex/Sexual Orientation/ Gender Identity/Religion/National Origin/Disability/Vets, VEVRRA Federal Contractor.