Quality Assurance Analyst

Gift of Life Michigan; Ann Arbor (MI); On-site; USD 43,000 - 46,000; Full time

Job summary

Gift of Life Michigan is seeking a Quality Assurance Analyst to serve as the QA liaison for donor records, regulatory reporting, and patient safety. You will support the Quality Management System, review and improve documentation, and ensure regulatory readiness.

The role requires a health sciences degree or equivalent, and four years in QA or related work, with strong communication and organizational skills to handle audits and CAPA activities.

Qualifications

• Bachelor’s degree in health sciences or equivalent combination of education and experience.
• Four years of work experience in a quality or related role.

Responsibilities

• Review, process, and maintain donor records for accuracy, timeliness, and regulatory compliance.
• Compile, monitor, and review donor documentation to support timely completion.
• Identify and resolve donor record discrepancies with appropriate parties.
• Maintain access to EMR systems and interpret clinical results to support donor records.
• Submit regulatory reports and support data management and QA documentation.

Skills

English proficiency

Critical thinking

Problem solving

Organizational skills

Attention to detail

Regulatory knowledge

Education

Bachelor's degree in health sciences

Tools

Microsoft Office

EMR systems

Job description

Job Details: Job Location: Ann Arbor MI - Ann Arbor, MI 48108, Position Type: Full Time, Education Level: 4 Year Degree, Salary Range: $31.00 - $33.38 Hourly, Travel Percentage: None, Job Shift: Day, Job Category: QA - Quality Control, Summary

In alignment with Gift of Life Michigan’s core purpose and core values, the Quality Assurance Analyst serves as the department’s quality liaison for quality assurance activities, donor record review, regulatory reporting, patient safety, and quality improvement activities. This role reviews, processes, and maintains donor records and quality assurance documentation to ensure accuracy, completeness, and regulatory compliance. The Quality Assurance Analyst supports the organization’s Quality Management System through regulatory reporting, compliance monitoring, data management, and other quality assurance activities that support regulatory readiness and patient safety.

The following job duties and responsibilities are stated in broad terms and not intended to be inclusive. Those in bold are essential duties of the position:

• Review, process, and maintain donor records to ensure accuracy, completeness, timeliness, and compliance with federal, state, accreditation, and other third-party regulations and standards, as well as organizational policies and procedures.
• Compile, monitor, and review donor record documentation to support timely completion.
• Identify, investigate, monitor, and resolve donor record discrepancies, collaborating with appropriate parties to ensure timely and accurate resolution.
• Maintain access to electronic hospital medical record (EMR) systems. Obtain, review and interpret relevant clinical results and assess patient information to support donor record completion and patient safety inquiries.
• Distribute donor record information in accordance with defined timeframes as specified in partner contracts, organizational policies, and regulatory requirements.
• Review and report positive serological, culture, and other post procurement donor test results to appropriate personnel and agencies, to support regulatory compliance.
• Support the organization’s Quality Management System by performing quality assurance activities that uphold regulatory compliance, patient safety, and continuous performance improvement.
• Complete regulatory reporting, data management, and quality assurance documentation within established timeframes to support compliance and organizational performance.
• Provide education and guidance to staff regarding quality assurance processes, regulatory requirements, organizational policies, procedures, and documentation expectations. Support the onboarding and training of new QA Analyst staff.
• Assists with additional responsibilities and special projects assigned by management in effort to identify opportunities for improvement.
• Assists with internal and externals audits by preparing documentation, responding to information requests, and supporting audit readiness and accreditation activities.
• Submit customer complaints, quality events, and non-conformances related to donor record documentation in the electronic Quality Management System.
• Participate in departmental meetings, committees, and cross-functional workgroups that support quality, compliance, and continuous improvement initiatives.
• Prioritize and manage daily responsibilities to ensure established deadlines, quality metrics, and departmental goals are consistently met.
• Perform other duties as assigned.

Supervisory Responsibilities

None

Qualifications: Education and/or Experience

Required

• Bachelor’s degree in health sciences or a combination of education and experience.
• Four years of work experience within a quality or related role.

Preferred

• Prior experience in a healthcare organization, transplant center, or organ/tissue procurement organization.

Knowledge, Skills, and Abilities (KSA)

• Written and verbal fluency in English.
• Ability to exercise initiative, critical thinking, and problem-solving.
• Proficiency with Microsoft Office programs, including Outlook and Teams and other technology systems used in business operations.
• Strong organizational skills and ability to manage multiple and competing priorities.
• Demonstrate attention to detail.
• Excellent verbal and written communication.
• Knowledge of quality assurance activities and quality improvement methodologies, including Corrective Action and Preventive Action (CAPA).

Organizational Culture Expectations

• Demonstrate the competencies of Professional, Determined and Compassionate.
• Maintain a motivated and positive attitude.
• Support an inclusive work environment.
• Ability to successfully collaborate and work as a member of an interdisciplinary team.
• Actively seek improvements.
• Always maintain a safe working environment and use Universal Precautions.
• Maintain appropriate level of confidentiality in all areas dealing with sensitive, protected, and confidential information.