Director of Quality Systems

Job Summary/Scope

The Director of Quality Systems will be responsible for planning and directing quality assurance, quality improvement, and quality control policies, programs, and initiatives. The Director of Quality Systems will be responsible for collaborating with the Executive Director, Medical Director and departmental Directors/Managers on the organization’s quality assurance processes and will conduct ongoing monitoring of internal and external process occurrences for trend analyses. This position will perform a variety of tasks in which a wide degree of creativity and latitude is expected. In addition, the position will ensure compliance with all pertinent regulatory standards and associated guidelines within each department. This position will be responsible for oversite of preparation of site surveys and audits by regulatory agencies such as CMS, AOPO, UNOS, FDA, and Tissue Processors who follow AATB guidelines, as well as demonstrate an ability to interpret and apply the regulatory standards and guidelines to the organizational process.

The job will not be limited to the Quality Assurance systems; it will include the Quality Assessment/ Performance Improvement (QAPI) processes that will enhance current goals to achieve excellence. Provides reports as needed for Continuous Quality Improvement (CQI) council or Executive Director.

Essential Functions

  1. Responsible for the supervision of Quality Systems staff.
  2. Communicates job expectations, planning, monitoring, coaching, counseling and appraising job results.
  3. Monitors and approves staff time records and overtime requests.
  4. Monitors and approves overtime and ensures cost is within designated budget.
  5. Follows and enforces systems including Standard Operating Procedures.
  6. Demonstrates an ability to interpret and apply the regulatory standards and guidelines to organizational processes.
  7. Facilitates inter/intra departmental functions and synergizes quality processes, including but not limited to, Quality Control (QC), Quality Assurance (QA), and Quality Improvement (QI).
  8. Ensures thorough and accurate compliance with all pertinent federal, local, national, and state regulatory agencies.
  9. Responsible for review of all Standard Operating Procedures (SOPs).
  10. Conducts ongoing monitoring of internal and external process occurrences, variance, and nonconformance for trends analysis and reporting; providing corrective action recommendations for process improvement.
  11. Collaborates with department directors to initiate and maintain accreditation status with applicable regulatory bodies.
  12. Monitors and analyzes information release and activity pertaining to federal, state, and industry standards as it relates to regulatory compliance and organizational operation.
  13. Acts as Chair of the CQI Council.
  14. Oversees internal audits and external audits.
  15. Responsible for audit responses to regulatory agencies.
  16. Oversees the electronic quality management system.
  17. Responsible for system configuration and validation/verification.
  18. Collaborates with Executive Director to direct organizational and departmental data monitoring and analysis to ensure compliance, included but not limited to, external data reports from regulatory agencies, internal occurrence reports, dashboards, and process improvement.
  19. Collaborates with, assists, and provides Quality Systems department staff support to all members.
  20. Prepares reports to the Executive Director on compliance with CMS, FDA, UNOS, AOPO, and all AATB regulations.
  21. Collaborates with the Executive Director on the organization’s quality improvement process.
  22. Presents reports and data analyses to the Governing Board and Advisory Council as required by AOPO and CMS regulatory standards.
  23. Responsible for annual QAPI training.

Secondary Functions

  1. Maintains FDA registrations.
  2. Acts as Continuous Quality Improvement Team facilitator.
  3. Oversees the auditing process to include policies and procedures and donor case records.
  4. Collaborates with Director of Clinical Services to maintain all required data collection and analysis systems and tools including the electronic donor record system and a variety of Excel spreadsheets.
  5. Collaborates with Director of Clinical Services to ensure interdepartmental synergy and efficiency.
  6. Responsible for the organization’s IT Disaster recovery plan.

Management Functions

  1. Member of Directors Group participating in the development and implementation of organizational and strategic goals.
  2. Member of Leadership Team participating in the development of tactics to implement the strategic goals.
  3. Ensures implementation of strategic goals as they relate to the department.
  4. Responsible for preparing and monitoring departmental budget.
  5. Collaborates with Director of Finance regarding departmental fiscal responsibility.
  6. Ensures staff documentation completion and accuracy.
  7. Responsible for oversight, compliance, and monitoring of contractual agreements under area of responsibility.
  8. Authorized to negotiate contractual terms and request competitive quotes in accordance with financial policies on behalf of the organization.
  9. Develops, tracks, and reports Key Performance Indicators (KPI), departmental Continuous Quality Improvement (CQI) goals and monthly statistics utilizing techniques to test improvement efforts.
  10. Presents CQI departmental goals to CQI committee.
  11. Promotion of staff engagement including wellness initiatives.
  12. Presents departmental reports to Director’s Group, Leadership Team, and/or Board of Directors, as required.
  13. Expected to serve as spokesperson at public events as it relates to your area of responsibility.
  14. Collaborates with the Quality Systems Department to ensure policies and practices follow Standard Operating Procedures and are in compliance with accreditation, certification and regulatory agencies.
  15. Responsible for writing, revising, editing and proofreading job descriptions, SOPs, and related departmental documents.
  16. Responsible for cooperative management with other managers at ARORA to ensure that tasks and responsibilities of direct reports are completed timely and efficiently.
  17. Responsible for interviewing, hiring, orientation, counseling, discipline, and separation of direct report(s).
  18. Conducts annual evaluations, monitors professional development and annual competencies for direct report(s).
  19. With the approval of Executive Director serves on national committees.

Organizational Expectations

  1. Maintains regular and punctual attendance at assigned work location.
  2. Accurately document timekeeping records.
  3. Completes appropriate ARORA forms in a timely and thorough manner and maintains proper documentation activities. Examples includes training documentation, mileage, expenses, and other administrative forms.
  4. Exhibits and models ARORA’s conduct standards, mission, and organizational clarity (core purpose, core values, business definition, and strategic anchors) in all job functions and interactions both internal and external to ARORA.
  5. Attendance at staff meetings, training programs, and/or in-services meetings, as required.
  6. Demonstrates professional appearance, behavior and standards in all business dealings and interactions.
  7. Demonstrates professional conduct and behavior reflective of ARORA’s respect, honor, admiration and reverence for the donor and donor family.
  8. Fosters effective relationships with client representatives.
  9. Performs other duties as assigned.

Potential Risk Factors:

  1. Risk Exposure to Blood/Body Fluids: While performing some essential functions of your position, you may be exposed to blood or body fluids. Established procedures identify the appropriate personal protective measures that you should use when performing essential functions of your position. The ARORA Safety program will provide you with the appropriate procedures and guidelines in which you should perform the essential duties of your job. If you need additional training or resources, please see your supervisor or the ARORA Safety Officer.
  2. Repetitive Motion: While performing some essential functions of your position, you may be required to perform some functions repeatedly. When such tasks are not performed properly, injury can result.
  3. Minimum Weightlifting Requirement: While performing some essential functions of your position, you may be required to do some lifting, moving, pushing, or pulling. When such tasks are not performed properly, injury can result. Established procedures identify the precautions and/or equipment that should be used when performing this task. Must have the ability to lift minimum weight of 30 lbs.
  4. Prolonged Sitting, Standing, and Bending: While performing some essential functions of your position, you may be required to sit, stand, or bend for an extended period of time. When such tasks are not performed properly, injury can result. Established procedures identify the precautions and/or equipment that should be used when performing this task.
  5. Competency Evaluation: Competency evaluations are required for this position. Your supervisor will notify you when your evaluation is to be conducted.
  6. Training: You may need additional training to better understand the performance requirements of your essential job functions. Training classes are available and can be requested and/or assigned. Your attendance at such classes is mandatory.

Work Environment

  1. Works in normal office environment.
  2. Occasional travel required by personal vehicle to fulfill the duties and responsibilities of the position.
  3. May require travel by commercial or chartered aircraft.
  4. Required to carry a cellular telephone for business purposes.
  5. Non-smoking office.
  6. Drug Free Workplace.

Work Hours

Forty-hour workweek with occasional weekends, holidays, or evenings.


Minimum Job Requirements

  1. Bachelor of Science or Bachelor of Art degree; preferably in health care administration or other health care related field, required. Master’s degree preferred.
  2. Minimum eight years Quality Systems or Master’s Degree plus six years health care related experience desired. 4 years management experience.
  3. Must possess effective presentation and strong interpersonal skills and demonstrate the ability to apply consistent standards with flexibility.
  4. Computer skills, including word processing, data entry, and spread sheets.
  5. Consistent demonstration of attention to detail, precision, accuracy, and customer satisfaction.
  6. Possess strong prioritization skills and the ability to effectively manage multiple projects and tasks.
  7. Excellent problem solving, conflict resolution and interpersonal skills (i.e. has the ability to make decisions based on situational circumstance, company policy and customer relations).
  8. Ability to utilize general office equipment, software, and must be proficient in Microsoft Office Suite.

Security Requirements

This position is responsible for handling confidential records and ensuring that information is protected according to the recognized standards and regulations for maintaining patient records.