Director of Quality Regulatory Affairs at Nevada Donor Network Inc – Miami Lakes, Florida

POSITION SUMMARY

The Director of Quality & Regulatory Affairs (DQRA) is responsible for assisting the Chief Quality Officer (CQO) with the execution of the SFDN Quality Management System including continual quality improvement throughout the organization. Directs the development, implementation and monitoring of quality systems and regulatory compliance related to internal standards, industry standards, state, local and federal regulations, departmental and organizational goals and processes. Assist with the overall direction for consistency and training for those managed. The Director serves as an advocate and resource for quality programs and provides interpretations of regulations and standards for consideration in the formulation of business strategies related to organ, tissue, and ocular recovery as well as administrative operations.

ESSENTIAL FUNCTIONS

Essential Functions Statement(s)

• Directs, manages, and provides oversight for all activities related to the Quality Management System (QMS) and performance improvement.

o Develops and maintains a quality plan to ensure the best service possible. Oversees the implementation of the SFDN’s QMS. At a minimum, activities will include and are not limited to Licensing, Performance Improvement, Customer Complaint, Planned Deviation, Corrective Action/Preventive Action, Auditing, Document Control, Chart QA, Validation, and Death Record Review Systems.

o Promotes quality assurance with the expectation of accurate donor medical records and data elements, and validation of all performance data.

o Implements, monitors and reviews systems and programs instituted to provide consistent adherence to policies related to organ, tissue and ocular recovery, laboratory, and administrative operations.

o Responsible for the administration of the electronic quality management system platform.

• Ensures organizational compliance with regulatory standards including AHCA, AOPO, OPTN/HRSA, CDC, and CMS. Ensures all regulatory and governmental licenses are kept current.

a. Monitors and analyzes information release and activity pertaining to federal, state, and industry standards as it relates to regulatory compliance and organizational operations.

b. Ensures policies and procedures reflect regulations and standards and collaboratively leads the revision of policies and procedures, as needed to reflect any applicable regulatory changes.

• Will be listed as the Patient Safety Contact with OPTN/HRSA as well as serve as the Patient Safety Officer.

a. The Patient Safety Officer will be responsible for monitoring and investigating patient safety events in real time, serving as the first point of contact for families, hospital partners, and HRSA; documenting and reporting incidents and adverse events to OPTN.

• Develops, oversees and maintains a quality plan that aligns to the SFDN Quality Manual and Quality Excellence Program (QEP) in order to advance the SFDN mission and core purpose.

• Deploys and maintains an effective QMS to foster a culture of continuous improvement through data analysis in collaboration with all SFDN departments.

a. Promotes use of the organization’s quality improvement process by evaluating, improving, improving workflow, and maximizing process efficiencies.

• Assists in the development and analysis of all statistical performance measurements of organ, tissue, and administrative operations, and quality and regulatory compliance throughout the organization. Conducts ongoing monitoring and data analysis, trending and reporting of the quality management systems including but not limited to occurrences (non-conformances), planned deviations, customer complaints, sentinel events, and adverse reactions and outcomes. Identify opportunities for improvements.

a. Reports meaningful data related to activity levels, quality measures, and regulatory compliance to SFDN leadership, staff, advisory board members, and various stakeholders.

• Collaborates with other organ, tissue and recovery agencies to keep current on industry best practices and works to deploy the same in the organization.

• Represents SFDN at various meetings and conferences including the Association of Organ Procurement Organization (AOPO). Promotes SFDN and the brand through actively participating and presenting at these conferences.

• Manages the selection, training, development, and performance of assigned staff to retain a motivated, professional workforce for the department.

• Recruits and selects applicants for job vacancies considering the requirements of the job and the skills/abilities of the applicants.

• Establishes and communicates job responsibilities as well as employee performance expectations to assure mutual understanding of desired results.

• Identifies training and/or development opportunities that will assist the employee in achieving enhanced job performance and/or career objectives.

• Constructively coaches and counsels for success to seek optimal employee performance.

• Builds support and alliances between and among departments to promote the organizational core values.

• Conducts performance reviews in alignment with job expectations, as well as reviews salary accordingly.

• Develop and maintain an internal audit program to ensure the application of organization policies and procedures as well as the adherence to applicable regulatory and accrediting regulation and standard requirements in the actions of the organization.

a. Oversees all phases of audits initiated by regulatory agencies and external customer-initiated audits.

b. Liaison for formal resolutions to compliance concerns brought forth by auditors including regulatory bodies.

c. Oversees all phases of the organization’s qualification audits of its vendors.

• Maintains the document control system for the organization

a. Assists in the review, creation, update, and maintenance of all organizational standard operating policies and procedures. Ensures that all policies and procedures are in compliance with applicable local, state, federal, and industry standards and regulations.

b. Utilizes the electronic quality management system platform to maintain the document control system for the organization’s-controlled documents.

c. Ensures all staff receive and adequately complete read acknowledgement training on all relevant controlled documents.

• Manages the non-conformance reporting system to ensure adequate and effective corrective and preventive actions are taken.

• Oversight for positive serology reporting in accordance with local, state, and federal regulations and accrediting standards.

• Oversight for organizational training related to quality tools through internal and external sources.

• Plan and uphold departmental budget through strategic planning in collaboration with Senior Leadership Team to support the goals of the organization.

• As appropriate, develops or assists in development of verification or validation of equipment, processes, and electronic systems.

• Perform other duties as assigned.

• Employees must adhere to and remain in full compliance with South Florida Donor Network’s Motor Vehicle Driving Policy as outlined in the Motor Vehicle Records and Driver Safety policy PC.334.

Reasonable Accommodations Statement

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable Accommodations may be made to enable qualified individuals with disabilities to perform the essential functions.

POSITION QUALIFICATIONS

Competency Statement(s) – Position Specific

• Accuracy - Ability to perform work accurately and thoroughly.

• Analytical Skills - Ability to use thinking and reasoning to solve a problem.

• Autonomy - Ability to work independently with minimal supervision.

• Coaching and Development - Ability to provide guidance and feedback to help others strengthen specific knowledge/skill areas.

• Ethical - Ability to demonstrate conduct conforming to a set of values and accepted standards.

• Leadership - Ability to influence others to perform their jobs effectively and to be responsible for making decisions.

• Management Skills - Ability to organize and direct oneself and effectively supervise others.

• Problem Solving - Ability to find a solution for or to deal proactively with work-related problems.

• Technical Aptitude - Ability to comprehend complex technical topics and specialized information.

• Tolerance - Ability to work successfully with a variety of people without making judgments.

Competency Statement(s) – Company Specific

• Understand and commit to the following:

o Organizational Core Purpose: To save and heal lives.

o Core Values: Relentless, Joyful, Selfless.

o Strategic Anchors: Mutually beneficial partnerships, diverse revenue streams and get to yes: every donor every time

• Accountability - Ability to accept responsibility and account for his/her actions.

• Adaptability - Ability to adapt to change in the workplace.

• Communication, Oral - Ability to communicate effectively with others using the spoken word.

• Communication, Written - Ability to communicate in writing clearly and concisely.

• Diversity Oriented - Ability to work effectively with people regardless of their age, gender, race, ethnicity, religion, or job type.

• Judgement - The ability to formulate a sound decision using the available information.

• Team Builder - Ability to convince a group of people to work toward a goal.

• Compliance – Ability of the individual to be in accordance with established guidelines, policy, standards or legislation.