LifeLink Foundation · 2 months ago
Executive Director, FDN Quality Systems
LifeLink Foundation is a mission-driven organization dedicated to saving lives through organ and tissue donation. The Executive Director of Foundation Quality Systems will manage and execute the Quality Assessment Performance Improvement plan, ensuring compliance with regulatory standards and overseeing quality managers.
CharityHealth CareMedicalNon Profit
Responsibilities
Oversees the development, implementation, and maintenance of quality assurance systems and activities including but not limited to document control, auditing, training, variances, CAPAs/RCAs, PDSAs, etc
Works closely with the OPO Directors to review external regulatory agency (CMS, OPTN, AOPO, etc.) requirements, including regular review of standards and available measurements ensuring compliance with requirements and reporting
Provides oversight and audit of all data and documentation required for submission to meet deadlines for federal and state certifications and scheduled data submissions to UNOS, SRTR, AOPO, and other entities as required
Development of an OPO audit process to include: scheduling, frequency, sampling procedures and reporting
Responsible for ongoing facilitation of policy review and approval process, in conjunction with the policy review committee, through designated LifeLink platform; this includes participation in ongoing policy review committee meetings; facilitation of interim policy revision and approvals recommended via internal committee and external regulatory change; and coordination of annual policy review, revision, approval and implementation per LifeLink policy
Works with tissue partners to ensure requirements are reflected in OPO policies as appropriate
Responsible for participation in quarterly Process/ Performance Improvement Committee (PIC) meetings including attendance and active participation in all standing committees of the PIC, ensuring committee goals and actions are congruent with the OPO Quality Assessment Performance Improvement Plan
Ensures compliance with and ongoing evaluation of OPO Quality Assessment Performance Improvement Plan in conjunction with all LifeLink OPOs and LifeLink Foundation designated staff
Responsible for the development, review, and implementation of training and educational programs applicable to quality and/or compliance with internal and external regulations. Facilitates consistent documentation in applicable LifeLink platforms
Participates in CMS, UNOS, AOPO and any other audits/surveys, as required
Provided oversight for the OPO variance documentation process
Continuously identifies areas of improvement through data and process analysis for the OPOs
Facilitates the incorporation of value stream mapping and deliverables into practice for QA processes
Participates in the testing and validation of new iTx releases, updating protocols/guidelines and policies as needed
Maintains professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; participating in professional societies
Serves as a liaison and maintains professional relationships and rapport with LifeLink leadership and staff
Assists in the development and analysis of all statistical performance measurements of organ activity, quality and regulatory compliance. Conducts ongoing monitoring of occurrences, variances, complaints and adverse outcomes for trends analysis and to ensure consistent quality practices
Qualification
Required
Nursing, PA, or Bachelor's degree in a Biological Science or Business or equivalent, Master's Degree preferred
Minimum of two to four years of experience with Quality Assurance/Process Improvement processes and prior management experience a plus
Demonstrates critical thinking in an effort to analyze data that monitors department trends and identify action items to improve performance
Must possess interpersonal skills necessary to interact with all levels of staff
Advanced knowledge of medical terminology
Advanced knowledge of computer-based skills, including word processing and spreadsheet development utilizing Microsoft Office Suite required
Must be able to function independently and have the ability to interpret regulations and their relevancy
Strong verbal and written communication skills
Ability to analyze documentation and identify breaches in policy
Strong organizational skills, ability to multi-task and attention to detail required
A collaborator who thrives in a mission-first environment
Preferred
Master's Degree preferred
Specific training in Quality Assurance/Process Improvement such as Total Quality management (TQM), LEAN, Six Sigma, American Society of Quality - ASQ CQMOE or equivalent, ASQ CQA, with or without a Certified Procurement Transplant Coordinator (CPTC) certification preferred
Benefits
COMPANY PAID Medical, Dental, Disability & Life Insurance
Generous COMPANY PAID Pension Plan for your Retirement
Paid Vacation, Sick Days & Holidays
Growth opportunities in a mission-driven, high-impact nonprofit
Company
LifeLink Foundation
LifeLink Foundation is a non-profit community service organization dedicated to the recovery of life-saving and life-enhancing organs and tissue for transplantation therapy.
Funding
Current Stage
Late StageRecent News
St Pete Catalyst
2025-04-30
Company data provided by crunchbase