Quality Assurance Engineer — Medical Devices & Compliance

Abbott; Alabama; On-site; USD 61,000 - 123,000; Full time

Benefits offered by this job

Free medical coverage

Excellent retirement plan

Tuition reimbursement

FreeU education benefit

Global employer with diversity

Job summary

Abbott in Madison, Wisconsin, is hiring a Quality Assurance Engineer to oversee manufacturing processes, equipment, and QC systems throughout their lifecycle. You will participate in qualification, validation, investigations, CAPA, and regulatory compliance in a fast-paced, regulated environment.

The role emphasizes cross-functional collaboration with Facilities, Service & Metrology, Process and Controls Engineering, and Production to ensure product quality and continuous improvement.

Qualifications

• Bachelor's degree in a science or technical field or an associate degree with 2 years of relevant experience.
• 3+ years of experience in a manufacturing operations environment.
• 1+ years applying quality principles in areas such as Design Transfer or Manufacturing Quality.
• 1+ years experience with process/test method validation or equipment qualification.
• Experience in FDA 21 CFR 820, ISO 13485, ISO 9001, or cGMP environments.
• Ability to travel up to 15%
• US work authorization without sponsorship

Responsibilities

• Provide Quality Engineering oversight of manufacturing processes, instruments, equipment, facilities, utilities, and systems.
• Review and assess engineering and manufacturing changes for quality impact and regulatory compliance.
• Lead or support investigations into deviations, nonconformances, and calibration issues.
• Support CAPA, risk assessments, and root-cause investigations to drive improvements.
• Oversee design and technology transfer activities, including qualification and validation.
• Collaborate with engineering and operations to evaluate process improvements and changes.
• Review and approve Quality Management System records and change controls.
• Exercise independent QA judgment on technical issues and compliance risks.

Skills

Manufacturing operations experience

Quality principles

Process/test method validation

Equipment qualification

Regulatory compliance

Travel readiness

US work authorization

Design transfer

Risk management

Education

Bachelor's degree in science/engineering or technical field

Associate degree + 2 years relevant experience

Job description

Abbott in Madison, Wisconsin, is hiring a Quality Assurance Engineer to oversee manufacturing processes, equipment, and QC systems throughout their lifecycle. You will participate in qualification, validation, investigations, CAPA, and regulatory compliance in a fast-paced, regulated environment.

The role emphasizes cross-functional collaboration with Facilities, Service & Metrology, Process and Controls Engineering, and Production to ensure product quality and continuous improvement.