Quality Assurance Engineer – Medical Devices & GMP

Abbott (abbottcareers2 board); Madison (WI); On-site; USD 85,000 - 110,000; Full time

Job summary

Abbott in Wisconsin seeks a Quality Assurance Engineer to partner with Operations in the Cancer Diagnostics group. You will oversee quality systems and ensure equipment, processes, and facilities meet regulatory standards.

The role includes qualification, validation, risk management, investigations, change control, and continuous improvement to sustain product quality. Travel up to 15% may be required.

Qualifications

• Bachelor's degree in a science or technical field required.
• Three+ years in a manufacturing operations environment.
• One+ years applying quality principles in an area such as Design Transfer, Risk Management, or Manufacturing Quality.
• One+ years of experience with process or test method validation, equipment qualification, or related quality engineering activities.
• Experience in FDA 21 CFR 820, ISO 13485, ISO 9001, and/or cGMP environments.
• Ability to travel up to 15% (overnight or weekend travel).

Responsibilities

• Provide Quality Engineering oversight of manufacturing processes, instruments, equipment, facilities, utilities, and automated systems across lifecycle.
• Review changes for potential impacts to product quality, process performance, equipment qualification, validated state, and regulatory compliance.
• Lead or support investigations involving deviations, nonconformances, out-of-spec results, equipment failures, calibration issues, and monitoring excursions.
• Support CAPA to address quality issues and drive sustainable improvements.
• Provide Quality Engineering oversight of design and technology transfer activities, including qualification, validation, and risk management.
• Partner with engineering and operations to evaluate process improvements and equipment changes.
• Review and approve Quality Management System records, engineering docs, qualification/validation records, investigations, and change controls.
• Exercise independent Quality Engineering judgment to identify compliance risks and actions.

Skills

Quality engineering

FDA 21 CFR 820

ISO 13485

cGMP

Risk management

CAPA

Process validation

Manufacturing quality

Travel 15%

Education

Bachelor's degree in science or technical field

Associate degree + 2 years relevant experience

Job description

Abbott in Wisconsin seeks a Quality Assurance Engineer to partner with Operations in the Cancer Diagnostics group. You will oversee quality systems and ensure equipment, processes, and facilities meet regulatory standards.

The role includes qualification, validation, risk management, investigations, change control, and continuous improvement to sustain product quality. Travel up to 15% may be required.