Who we are? As the world's largest organization of board-certified pathologists and leading provider of laboratory accreditation and proficiency testing programs, the College of American Pathologists (CAP) serves patients, pathologists, and the public by fostering and advocating excellence in the practice of pathology and laboratory medicine worldwide. Our Culture + CAP employees make a meaningful difference by partnering with colleagues customers and members on challenging and rewarding work + CAP provides its employees with an energetic and collaborative work environment and encourage opportunities to further develop their skills—offering reimbursement for educational programs and participation in events that enhance your skills + We offer a generous compensation and benefits package, 401K, and more -- visit Careers at the CAP (https://www.cap.org/careers-at-the-cap) for more details Brief Description The Quality Manager, Quality & Process Improvement, is responsible for developing, implementing, and maintaining the CAP Quality Management System (QMS) in alignment with ISO 17043, ISO 9001, and other relevant standards. This role emphasizes compliance, operational efficiency, and collaboration with internal teams and external suppliers to enhance quality outcomes while minimizing financial impacts to the CAP and its partners . Specific Duties Primary duties and responsibilities of the Quality Manager, Quality & Process Improvement, include: ISO Compliance and Proficiency Testing (PT) + Develop and execute a comprehensive ISO 17043 compliance strategy for the PT division aligned with the company’s goals and objectives. + Support adherence to ISO 9001 and other quality standards across CAP operations. + Lead planning, coordination, and oversight of surveillance and inspection activities, ensuring audit readiness and effective resolution of non-conformances. + Manage external supplier audits, collaborating with Purchasing and Technical Buyers to align with ISO 17043 and GMP requirements. + Ensure full compliance with all necessary quality audits or related certifications. Partnership and Collaboration + Foster partnerships with internal business units and external suppliers to enhance compliance and drive quality improvements. + Lead initiatives that integrate quality management into product and service requirements and processes ensuring alignment with organizational goals. + Collaborate with senior leadership to integrate quality into the overall business strategy. Corrective Action and Preventive Action (CAPA) Ownership + Facilitate, lead, and administer CAPA processes with a project management approach, ensuring timely and effective resolution of non-conformances from internal and external audits. + Take full ownership and accountability for timely initiation, execution, and completion of CAPA processes, ensuring all actions are tracked and resolved within defined timelines. + Develop and maintain a risk taxonomy to support ongoing compliance and proactive issue management. + Ensure clear communication and collaboration among stakeholders to drive CAPA progress and adherence to deadlines. Quality Management System Administration + Oversee the QMS software (Reliance), including user support, module configuration, and enhancements. + Develop and implement training programs on QMS components, quality principles, and ISO 17043 and ISO 9001 standards for staff and new employees. + Oversee quality assurance processes ensuring adherence to agreed-upon standards. + Track, analyze, and resolve all quality issues in a timely manner. Process Improvement and Leadership + Ideate, organize, and lead cross-functional process improvement projects, applying Lean Six Sigma, Total Quality Management (TQM), and other quality frameworks. + Implement continuous improvement initiatives to enhance efficiency, reduce defects, and improve product quality that meets and exceeds customer expectations. + Provide technical and administrative guidance on performance monitors, operational efficiency, and quality management. Stakeholder Engagement and Education + Collaborate with CAP committees and industry organizations to integrate quality best practices into program requirements and deliverables. + Actively engage with healthcare and industry quality organizations to ensure timely information exchange and address emerging issues. + Lead quality discussions with all impacted stakeholders (internal and external) proactively resolving issues before they become critical. Performance Metrics and Risk Management + Guide the development, implementation, and reporting of performance monitors/metrics for evaluating PT program and LAP operations. + Manage risk identification and mitigation strategies to ensure continuous compliance with ISO standards and regulatory requirements. + Compile, analyze, and present metrics summarized in concise reports that provide a clear state of quality for PT programs, including efficiency, satisfaction, and compliance. + Monitor QMS performance, leveraging data to support continuous improvement initiatives. Knowledge/Skills Required/Preferred + Expertise in ISO 17043, ISO 9001, cGMP, CMS/CLIA, and quality management systems and continuous improvement methodologies. + Strong analytical, critical thinking, and presentation skills. + Proficiency in performance improvement frameworks and quality metrics development and reporting. + Demonstrated success in leading CAPA processes and driving resolution with a project management mindset. Technical knowledge of QMS software and quality standards. + Strong communication and facilitation skills. + Decisive, organized, and adaptable to changing priorities. + Collaborative mindset with a focus on building effective partnerships. Education/Experience Education + Bachelor’s degree in sciences, clinical laboratory, healthcare, operations, engineering, or related technical discipline required. + Advanced degree in technical or clinical disciplines or business highly preferred. Experience + Minimum of 7 years in quality or performance improvement management. + Quality management certifications (eg, Lean Six Sigma, ISO, TQM, ASQ) preferred. + Proven ability to manage cross-functional teams and initiatives with excellent communication and interpersonal skills. Additional Criteria + Travel required for committee meetings, supplier audits, client visits, and industry events, including possible weekend obligations. + This position is based out of the Northfield, IL office. Candidates must reside within 75 miles of the Northfield headquarters. + Salary Range: $120,000 - $140,000 Equal Opportunity Employer The CAP is an equal opportunity/affirmative action employer, providing equal employment opportunities (EEO) to all employees and qualified applicants for employment without regard to race, creed, color, religion, sex, gender identity and/or expression, national origin, age, ancestry, disability or genetic information, military status, sexual orientation, marital status, citizenship status, order of protection status, homelessness, or any other characteristic protected by federal law and the applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. Applicants have rights under Federal Employment Laws: Family and Medical Leave Act Equal Employment Opportunity Employee Polygraph Protection Act Job Details Job Family Operations Pay Type Salary