University Hospitals

Specialist, Quality and Regulatory Affairs

University Hospitals  •  Cleveland, OH (Onsite)  •  4 days ago
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Job Description

Specialist, Quality and Regulatory Affairs-(260004MA)

Joining our team comes with several benefits, including:

Competitive hourly rate

Free parking

Tuition reimbursement

A Brief Overview

This position is responsible for providing support to the quality and regulatory activities within Pathology - this position will support our anatomic pathology and cytopathology departments.

Areas of focuses for the Quality Department are driving overall process improvement, workflow mapping and development, conduct safety reviews, coordinate response efforts to nonconformances, development of educational content and tools to improve quality outcomes, and ensure compliance with regulatory and accreditation entities. This role manages ad hoc projects that fall into these categories for the system, as well as long-term initiatives, with the overarching goal of creating standardization to ensure the same, high quality experience for all patients interacting with UH Pathology.

What You Will Do

  • Lead internal and external regulatory surveys and inspections, and standardize response process across the system. Responsible for achieving and maintaining compliance with regulatory and accrediting agencies (e.g. CAP, CLIA, ODH, DNV, FDA, ASHI, etc.) for all laboratory sections and locations across all patient settings. Orders, monitors and coordinates proficiency testing survey program and ensures compliance with Clinical Laboratory Improvement Amendments (CLIA).
  • Develop Media Lab content in Compass and Document Control modules to align with strategic goals and regulatory standards, with the goal of achieving standardization policy and procedure organization across the system.
  • Serve as representative on a variety of Quality related committees to create system alignment in Quality and Regulatory affairs for the system, as well as disseminate recall and safety notices throughout the system.
  • Manage and develop system-wide database containing quality metrics for various laboratory sections. Pull data for quality indicator review for the various sections within pathology for review at Quality Management meetings, and facilitate Quality Management meetings. Coordinate development and implementation of action plans when metrics fall below acceptable threshold.
  • Participate in Learning From Defects reviews and project manage action items coming out of the meeting to close the loop on patient safety issues, as well as disseminate solutions and best practices to the system.
  • Manage partnerships with educational institutions, coordinate clinical rotations for students, and create pathways for existing employees to further their educated and become eligible for additional credentials/certification.
  • Provides analytical support related to operations and finance. Access and analysis of information to support key strategic initiatives. Monitors various reports and data. Work on assigned projects aimed at improving processes, enhancing revenue, and reducing costs.
  • Lead training sessions for external stakeholders regarding regulatory compliance. Lead internal training sessions regarding use of policy/competency assessment software (Media Lab) as well as training of new hires.

Additional Responsibilities

  • Performs other duties as assigned.
  • Complies with all policies and standards.
  • For specific duties and responsibilities, refer to documentation provided by the department during orientation.
  • Must abide by all requirements to safely and securely maintain Protected Health Information (PHI) for our patients. Annual training, the UH Code of Conduct and UH policies and procedures are in place to address appropriate use of PHI in the workplace.

Qualifications

Education

  • Bachelor's Degree In chemical, physical or biological science or medical laboratory (Preferred) and
  • Associate's Degree In chemical, physical or biological science or medical laboratory (Required) and
  • High School Equivalent / GED with documented training prior to 9/1/1997 and performance of high complexity training on or before 4/24/1995 (Required)

    Work Experience


    5+ years’ Experience working in the medical laboratory (Required) Anatomic Pathology (AP) experience preferred

  • Hands-on experience in anatomic pathology and/or cytopathology operations strongly preferred

  • 1–3 years of AP quality and/or regulatory experience preferred

  • Experience tracking and analyzing quality metrics (e.g., TAT, adequacy rates, discrepancies, amended reports), preferred

  • Experience supporting or participating in lab inspections and audits, preferred

Knowledge, Skills, & Abilities

  • Proficiency with Microsoft Office, including advanced knowledge of Excel (Required proficiency)

  • Proficiency with Laboratory Information Management Systems (LIMS) (Required proficiency)

  • Working knowledge of Media Lab (Preferred proficiency)

  • Working knowledge of Midas (Preferred proficiency)

  • Familiarity with PowerBI and/or other visualization software (Preferred proficiency)

  • Detail oriented (Required proficiency)

  • Self-motivated (Required proficiency)

  • Effective communication skills (Required proficiency)

  • Critical thinker with an innovative mindset (Required proficiency)

  • Strong knowledge of AP workflows, including specimen handling and slide preparation, preferred

  • Understanding of common risk areas in AP/cytology, preferred

  • Ability to trend data and drive process improvement, preferred

Licenses and Certifications

  • Medical Technologist (MT-ASCP) (Preferred) and
  • Medical Laboratory Scientist (MLS-ASCP) or equivalent certification (Preferred) and
  • Pathology/Cytologist (CT-ASCP) (Preferred) and
  • Medical Lab Technician (MLT-ASCP) (Preferred) or
  • Pathology/Histotechnician (HT-ASCP) or equivalent certification (Preferred)
  • Histotechnologist, HTL(ASCP) (Preferred)

Physical Demands

  • Standing Frequently
  • Walking Frequently
  • Sitting Rarely
  • Lifting Frequently 50 lbs
  • Carrying Frequently 50 lbs
  • Pushing Frequently 50 lbs
  • Pulling Frequently 50 lbs
  • Climbing Occasionally 50 lbs
  • Balancing Occasionally
  • Stooping Frequently
  • Kneeling Frequently
  • Crouching Frequently
  • Crawling Occasionally
  • Reaching Frequently
  • Handling Frequently
  • Grasping Frequently
  • Feeling Constantly
  • Talking Constantly
  • Hearing Constantly
  • Repetitive Motions Constantly
  • Eye/Hand/Foot Coordination Constantly

Travel Requirements

  • 10%

Primary Location

United States-Ohio-Cleveland

Work Locations

11100 Euclid Avenue
11100 Euclid Avenue
Cleveland44106

Job

Lab / Pathology

Organization

CMC_Operations

Schedule

Full-time

Employee Status

Regular-ShiftDays

Job Type

Standard

Job Level

Professional

Travel

Yes, 15 % of the Time
Remote WorkNo

Job Posting

Jun 8, 2026, 4:51:00 PM
University Hospitals

About University Hospitals

Founded in 1866, University Hospitals serves the needs of patients through an integrated network of 23 hospitals (including 5 joint ventures), more than 50 health centers and outpatient facilities, and over 200 physician offices in 16 counties throughout northern Ohio. The system’s flagship quaternary care, academic medical center, University Hospitals Cleveland Medical Center, is affiliated with Case Western Reserve University School of Medicine, Northeast Ohio Medical University, Oxford University and the Technion Israel Institute of Technology. The main campus also includes the UH Rainbow Babies & Children's Hospital, ranked among the top children’s hospitals in the nation; UH MacDonald Women's Hospital, Ohio's only hospital for women; and UH Seidman Cancer Center, part of the NCI-designated Case Comprehensive Cancer Center. UH is home to some of the most prestigious clinical and research programs in the nation, with more than 3,000 active clinical trials and research studies underway. UH Cleveland Medical Center is perennially among the highest performers in national ranking surveys, including “America’s Best Hospitals” from U.S. News & World Report. UH is also home to 19 Clinical Care Delivery and Research Institutes. UH is one of the largest employers in Northeast Ohio with more than 30,000 employees.

Industry
Healthcare & Social Services
Company Size
10,000+ employees
Headquarters
Cleveland, Ohio
Year Founded
Unknown
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