Donor Alliance is hiring a Quality Systems Coordinator in Denver! The Quality Systems Coordinator is responsible for monitoring and promoting quality as it relates to organizational goals, services, and work processes.  This position monitors organizational performance and fosters an environment for continuous quality improvement.  This position interacts with all levels of employees to promote quality systems, continuous quality improvement, and regulatory compliance related to organizational goals and industry standards.

Day-To-Day

Continuous Quality Improvement:

• Facilitates and/or participates in quality improvement projects to enhance quality and compliance of the organization.
• Coordinates the collection and reporting of process improvement data.
• Reviews and interprets data for accuracy.
• Utilizes quality improvement tools and methods, including but not limited to, PDSA’s, Pareto charts, cause/effect diagrams, flow charts, process mapping, control charts, and correlation analysis as part of ongoing quality improvement activities.
• Develops trend analyses of organizational performance data using statistical and/or quality tools, identifies areas for process improvement, and reports to Donor Alliance leadership, quality improvement teams, and the Quality Improvement Council, as needed.
• Acts as a resource to support the development of improved systems and processes.
• Actively participates in the Donor Alliance Quality Improvement Council.

Quality and Regulatory:

• Provides support and resources as required to meet quality/regulatory compliance requirements
• Demonstrates knowledge of applicable FDA, CMS, UNOS, AOPO, and AATB requirements.
• Participates in the planning, implementation and/or management of Donor Alliance audits as directed. Performs internal and supplier/vendor audits as assigned, and assists with onsite agency inspections and accreditation surveys as needed.
• Monitors recovery surgeon qualifications and activities, tracks organ recovery data, and maintains required documentation. Prepares and submits surgeon review reports to Donor Alliance Leadership for Quality Advisory Board meetings.
• Coordinates surgeon orientation activities.
• Reviews and evaluates reactive serology results from organ and tissue cases. Reports reactive serology results to appropriate individuals/agencies in accordance with state and federal laws, regulations and industry standards.
• Manages Donor Alliance’s Document Control System (DCS):
  • Reviews, analyzes, and determines applicability and change to SOPPs that allow the organization to achieve and maintain compliance.
  • Ensures appropriate confidentiality, security, tracking, release, storage, retrieval and retention of standard operating policies and procedures (SOPPs).
  • Provides support for the review, creation, update and maintenance of organizational SOPPs.
  • Without changing technical content, applies technical editing best practices as needed.
  • Facilitates the review and approval of new/revised/archived SOPPs by applicable staff.
  • Facilitates annual review of SOPPs with appropriate staff to ensure consistency with regulatory requirements and business practices.
  • Initiates, receives, edits, tracks, routes, releases, and distributes new and revised SOPPs.
  • Ensures archive and retention of inactive SOPPs within established timeframes.
  • Ensures accessibility of active SOPPs to Donor Alliance staff.
  • Facilitates staff training for new and/or revised SOPPs.
  • Acts as an administrator for the Document Control software system (Q-Pulse).
• Manages TrainCaster read and acknowledge SOPP and Work Instruction courses to ensure appropriate required reviews/acknowledgments are performed at both management and staff levels.

Corrective and Preventive Action (CAPA), Nonconformance Report (NCR) and Complaint Management Report (CMR) Systems:

• Maintains Donor Alliance’s CAPA, NCR, and CMR systems to ensure that events are documented, tracked, monitored, and closed.
• Receives incoming reports and coordinates and/or conducts investigations.
• Assists in resolving quality concerns and issues.
• Identifies and provides constructive guidance in finding solutions for improvement.
• Monitors CAPA, NCR and CMR status and provides ongoing communication in order to facilitate closure.
• Tracks, trends, and monitors data from CAPAs, NCRs, and CMRs with the goal of identifying areas for improvement. Reports trended data to Donor Alliance leadership, quality improvement teams, and the Quality Improvement Council as needed.
• In conjunction with Donor Alliance Leadership, coordinates and implements system improvements through complaint resolution, corrective and preventive action plans, and PDSA’s/Process Improvement Projects.
• Monitors and follows up on short-term corrections and/or long-term corrective/preventive actions for completion and review of effectiveness. Acts as an administrator for the quality management software system (QPulse).
• May perform other related duties as required to meet the ongoing needs of the organization.

Qualifications

• Undergraduate degree or equivalent of education and work experience in relevant field required.
• Minimum of five years combined experience in quality and regulatory systems.
• Proven performance in CQI processes.
• Certification through organizations such as American Society of Quality (ASQ) or National Association for Healthcare Quality (NAHQ) desired.
• Ability to concurrently manage multiple projects.
• Excellent written and verbal presentation skills required.
• Strong interpersonal skills and ability to work both independently and as part of a team is required.
• Proficiency in the use of computer equipment and software, including but not limited to, Windows environment (Word, Excel, Outlook – Intermediate to Advanced skills) required.