Quality Engineer (Associate) — Manufacturing & Compliance

Abbott; United States; On-site; USD 31,000 - 62,000; Full time

Job summary

Abbott in Madison, Wisconsin is seeking a Quality Assurance professional to partner with Operations, reviewing production records, test methods, and disposition decisions before distribution to ensure compliance with cGMP, ISO, ICH, and internal standards.

You will support nonconformance investigations, assess process risks, and help improve manufacturing quality processes, while reviewing SOPs and conducting audits.

Qualifications

• Bachelor's degree in engineering, science, or related field (or associate degree with 2+ years' experience).
• 2+ years of experience in manufacturing operations.
• 1+ years applying quality principles and practices.
• Experience in 21 CFR Part 820, ISO 13485, ISO 9001, or cGMP environments.
• Strong communication and collaboration across Operations and Quality teams.
• Willingness to be onsite at least 90% of the time and travel as needed.
• Authorized to work in the United States without sponsorship.

Responsibilities

• Partner with Operations as a Quality representative to review production records, test methods, and disposition decisions.
• Review validation, qualification, calibration records; identify deficiencies.
• Support nonconformance investigations, assess process risks, and recommend mitigations.
• Review and approve SOPs and work instructions; conduct production-area audits.
• Collaborate with cross-functional teams to resolve quality concerns and drive continuous improvement.

Skills

Communication

Collaboration

Education

Bachelor's degree in engineering/science

Associate degree + 2 years experience

Job description

Abbott in Madison, Wisconsin is seeking a Quality Assurance professional to partner with Operations, reviewing production records, test methods, and disposition decisions before distribution to ensure compliance with cGMP, ISO, ICH, and internal standards.

You will support nonconformance investigations, assess process risks, and help improve manufacturing quality processes, while reviewing SOPs and conducting audits.