Quality Assurance Engineer

Abbott seeks a Quality Assurance Engineer to support its Cancer Diagnostics business operations in Madison. The role involves providing quality oversight of manufacturing processes, equipment, facilities, and systems through validation, risk management, investigations, and continuous improvement activities.

Responsibilities

• Provide quality engineering oversight of manufacturing processes, instruments, equipment, facilities, utilities, and automated systems throughout their lifecycle
• Review and assess engineering and manufacturing changes for impacts to product quality and regulatory compliance
• Lead or support investigations of manufacturing deviations, nonconformances, equipment failures, and process monitoring excursions
• Partner with engineering and operational teams to evaluate process improvements and equipment modifications
• Review and approve quality management system records, engineering documentation, and change controls

Requirements

• Bachelor's degree in science or technical field, or associate degree plus two years relevant experience
• Three or more years in manufacturing operations environment
• One or more years applying quality principles in design transfer, risk management, or manufacturing quality
• One or more years with process validation, equipment qualification, or quality engineering activities
• Demonstrated ability in FDA 21 CFR 820, ISO 13485, ISO 9001, or cGMP environments
• Authorization to work in the United States without sponsorship
• Ability to travel up to 15%, including potential overnight and weekend travel