Director of Quality

Director of Quality

LifeSource is hiring a Director of Quality to serve as a strategic leader responsible for designing, implementing, and sustaining a comprehensive quality management system across all organizational operations. This role ensures full alignment with the organization's mission and strategic goals, while maintaining rigorous adherence to regulatory, safety, and accreditation standards. As the appointed OPTN Safety Officer, the Director leads efforts to foster a culture of safety, transparency, and continuous improvement. This position oversees quality assurance, regulatory compliance, patient safety, and enterprise risk management, driving operational excellence and accountability throughout the organization. This Director also drives enterprise-wide process improvement initiatives by applying Lean, Six Sigma, and other quality methodologies to enhance operational efficiency and product / service excellence. Leads root cause analysis and corrective action planning to resolve systemic issues, reduce waste, and improve performance. Establishes and monitors key quality metrics to ensure continuous improvement and regulatory compliance, while fostering a culture of accountability and innovation across cross-functional teams.

As the Director of Quality, you'll advance our life-saving work by performing the following job duties :

Strategic Quality Leadership

Develop and lead the organization's quality management system, ensuring alignment with strategic priorities, regulatory requirements, and performance goals. Partner with executive leadership to embed quality and safety principles into organizational strategy, fostering cross-functional collaboration and accountability. Drive enterprise-wide quality initiatives that support continuous improvement, risk mitigation, and operational excellence.

Regulatory Compliance & Accreditation

Ensure compliance with all applicable federal, state, and OPTN / UNOS regulations, including CMS and HRSA standards. Develop and enforce regulatory and compliance policies to ensure adherence to all relevant federal, state, and local laws, as well as industry standards (UNOS, CMS, FDA, AOPO, AATB). Lead preparation for audits, inspections, and accreditation reviews. As necessary, act as the organization's point of contact for regulatory site visits, audits, and inspections, managing interactions and documentation with regulatory bodies. Accountable for corrective action related to non-conformities or opportunities for improvement from surveys / audits and reports them through the QAPI Committee. Supports the process for conducting donor chart quality assurance reviews. Directs and supports the team to identify quality improvement issues with chart reviews and partners with corresponding teams to create awareness and change in process.

Quality Management Systems

Directs the organizational quality management system, encompassing document control, error / accident management, complaint management, adverse outcome investigation, supplier quality approval, training, equipment management, validations, process reviews. Acts as subject matter expert for the electronic record control system. This includes set-up, maintenance, and configuration of the modules within the system. The modules include Document Control, CAPA, Audit, People, Training, Suppliers, Assets, Risk Analysis, and Administration. Responsible for training associated with the electronic document control system and responsible for leader's compliance with closing of CAPAs per organizational policy. Provides ongoing education to staff on quality systems, Lean methodologies, and regulatory compliance. Chairs the Quality Assurance and Performance Improvement (QAPI) Committee and participates in quality improvement initiatives within the organization, as warranted.

Safety Oversight

Serve as the designated OPTN Safety Officer, overseeing the identification, investigation, and resolution of safety events. Promote a proactive safety culture through education, reporting, and system-wide engagement.

Risk Management

Oversee organizational risk assessment and mitigation strategies. Monitor trends and develop data-driven solutions to reduce risk and improve outcomes.

Enterprise-wide Process Improvement Initiatives

Lead strategic quality initiatives that drive continuous process improvement across key operational areas. Champion Lean, Six Sigma, and other methodologies to optimize efficiency, reduce waste, and elevate product / service quality. Collaborate cross-functionally to identify performance gaps, conduct root cause analysis, and implement sustainable corrective actions.

Working Conditions : Full-time, exempt position. This position is hybrid on-site in Minneapolis with a minimum of 3 days / week on-site. Projected offer rate range : $160-200k / year, based on relevant experience.