Quality Assurance Engineer, Medical Devices & Diagnostics

Abbott; Madison (WI); On-site; USD 61,000 - 123,000; Full time

Job summary

Abbott in Madison, Wisconsin is seeking a Quality Assurance Engineer to provide quality oversight across manufacturing processes, equipment, and facilities within Cancer Diagnostics operations. You will work with cross-functional teams to ensure validated state, risk management, and CAPA-driven improvements in a regulated environment.

The role requires collaboration with Facilities, Metrology, Process and Controls Engineering, and Production teams to ensure product quality meets FDA/ISO

Qualifications

• Bachelor's degree in science or technical field; or an associate degree with 2 years of relevant experience.
• 3+ years in a manufacturing operations environment.
• 1+ years applying quality principles in Design Transfer, Risk Management, or Manufacturing Quality.
• 1+ years in process or test method validation, equipment qualification, or related quality engineering activities.
• Experience in FDA 21 CFR 820, ISO 13485, ISO 9001, or cGMP environments.
• Ability to travel up to 15% and work in the United States without sponsorship.

Responsibilities

• Provide Quality Engineering oversight of manufacturing processes, equipment, facilities, utilities, and automated systems, including qualification and validation.
• Review changes for potential impacts to product quality, process performance, equipment qualification, validated state, and regulatory compliance.
• Lead or support investigations involving deviations, nonconformances, calibration issues, and environmental monitoring excursions.
• Support risk assessments and CAPA to address quality issues and drive improvements.
• Provide oversight of design and technology transfer activities, including qualification, verification, validation, and manufacturing readiness.
• Collaborate with engineering and operations to evaluate process improvements and changes.
• Review and approve QMS records, documentation, investigations, and change controls for compliance.
• Apply independent Quality Engineering judgment on technical issues and compliance risks.

Skills

Quality Assurance

Process Validation

Risk Management

CAPA

Investigations

Regulatory Knowledge

Education

Bachelor's degree in science/technical field

Associate degree + 2 years experience in lieu of degree

Tools

eQMS

PLM

Equipment asset management

Job description

Abbott in Madison, Wisconsin is seeking a Quality Assurance Engineer to provide quality oversight across manufacturing processes, equipment, and facilities within Cancer Diagnostics operations. You will work with cross-functional teams to ensure validated state, risk management, and CAPA-driven improvements in a regulated environment.

The role requires collaboration with Facilities, Metrology, Process and Controls Engineering, and Production teams to ensure product quality meets FDA/ISO