Associate Quality Assurance Engineer, Manufacturing

Abbott; Madison (WI); On-site; USD 31,000 - 62,000; Full time

Benefits offered by this job

Health coverage

Retirement plan

Tuition reimbursement

Education benefit

Diversity & inclusion

Job summary

Abbott in Madison, Wisconsin, is seeking an Associate Quality Assurance Engineer to partner with Operations to ensure manufacturing processes, materials and products meet quality and regulatory standards.

You will support validation and qualification activities, investigate quality issues, review production documentation, and assess materials for release while contributing to process improvement and operational excellence.

Qualifications

• Bachelor’s degree or higher in engineering or science with biology/chemistry focus.
• 2+ years in a manufacturing environment.
• Knowledge of quality principles and regulatory requirements (21 CFR Part 820, ISO 13485, ISO 9001, cGMP).

Responsibilities

• Review production records and test methods to ensure compliance before release.
• Validate processes and equipment qualifications; assess calibration records and deficiencies.
• Investigate nonconformances, deviations, and process risks; propose mitigations.
• Review SOPs and work instructions; perform production-area audits for regulatory compliance.
• Collaborate with Operations and Quality teams to resolve issues and drive continuous improvement.

Skills

Quality assurance

Cross-functional collaboration

Regulatory compliance

Documentation and record-keeping

On-site work readiness

Education

Bachelor’s degree in engineering/science

Associate degree with 2+ years experience

Tools

GMP/ISO knowledge

ISO 13485 familiarity

Job description

Abbott in Madison, Wisconsin, is seeking an Associate Quality Assurance Engineer to partner with Operations to ensure manufacturing processes, materials and products meet quality and regulatory standards.

You will support validation and qualification activities, investigate quality issues, review production documentation, and assess materials for release while contributing to process improvement and operational excellence.