Manager, Laboratory Supplier Quality

Minimum Qualifications

• Bachelor's Degree in a scientific field, engineering, quality, regulatory affairs, clinical laboratory science, medical technology, or another discipline related to the essential duties of the position.
• 10+ years of experience in supplier quality, quality assurance, regulatory compliance, laboratory operations, or related quality functions within a regulated industry.
• 6+ years of experience leading cross-functional teams, enterprise initiatives, quality programs, or complex projects.
• Demonstrated experience developing, implementing, and managing supplier qualification, supplier monitoring, supplier auditing, supplier risk management, and supplier corrective action programs.
• Demonstrated experience developing, implementing, and maintaining Quality Management System procedures and practices.
• Strong knowledge of applicable regulations and standards affecting laboratory operations and healthcare products, including CLIA, CAP, ISO 15189, FDA Quality System Regulations, ISO 13485, and applicable state requirements.
• Demonstrated ability to lead enterprise-wide quality initiatives, influence quality strategy, and guide leadership in compliance and risk-based decision making.
• Exceptional written, verbal, and interpersonal communication skills.
• Strong analytical, organizational, project management, and problem-solving skills.
• Demonstrated ability to perform the essential duties of the position with or without accommodation.
• Authorization to work in the United States without sponsorship.

• Lead the laboratory supplier quality program across the clinical laboratory enterprise, ensuring compliance with CLIA, CAP, ISO 15189, company policies, and applicable regulatory requirements.
• Serve as the primary Laboratory Quality representative within the enterprise supplier management program, providing strategic oversight of supplier qualification, approval, governance, risk management, and quality agreements.
• Provide quality and regulatory oversight of suppliers supporting laboratory operations and lead supplier issue management activities, including investigations, corrective actions, audits, assessments, and supplier-related change evaluations.
• Identify, assess, and mitigate supplier-related risks impacting quality, patient safety, regulatory compliance, operational continuity, and inspection readiness.
• Establish and monitor supplier quality metrics, performance indicators, and management review processes while driving standardization, continuous improvement, and long-term supplier performance strategies across laboratory sites.
• Serve as a supplier quality subject matter expert and trusted advisor to leadership, supporting regulatory inspections, accreditation activities, enterprise quality initiatives, and the development of a culture of quality, compliance, and continuous improvement.
• Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.
• Support and comply with the company's Quality Management System policies and procedures.
• Maintain regular and reliable attendance.
• Ability to act with an inclusion mindset and model these behaviors for the organization.
• Ability to work designated schedule.
• Ability to work nights and/or weekends, as needed.
• Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 90% of a typical working day.
• Ability and means to travel between company locations.
• Ability to travel up to 5% of working time away from work location, which may include overnight and weekend travel.