Associate Quality Engineer

Abbott • Madison, WI

1d • Onsite

About The Position

Abbott is seeking an Associate Quality Assurance Engineer to support its Madison, Wisconsin locations within the Cancer Diagnostics business. The role partners with Operations to help ensure manufacturing processes, materials, and products meet quality and regulatory requirements. It supports validation and qualification activities, quality-issue investigations, production documentation review, material assessments for commercial release, and continuous process improvement.

The position is based onsite at least 90% of the time and may require travel between Madison locations and up to 5% travel away from the work location, potentially including overnight or weekend travel. The role involves meeting applicable PPE requirements and performing physical activities such as lifting up to 40 pounds, with or without reasonable accommodation. Work activities also include prolonged sitting and keyboard use for at least 50% of the workday.

The posted base pay is $22.45–$44.85 per hour; the range may vary in specific locations.

Requirements

• Bachelor’s degree in engineering, science with a focus on biology and/or chemistry, or a related field; alternatively, an associate degree in a related field with an additional two years of experience.
• At least 2 years of experience in a manufacturing operations environment.
• At least 1 year of experience applying quality principles and practices.
• Knowledge of and experience working within a 21 CFR Part 820, ISO 13485, ISO 9001, and/or cGMP-regulated environment.
• Strong communication and collaboration skills, with the ability to work effectively across Operations and Quality teams.
• Ability to work onsite at least 90% of the time, travel between Madison locations, and travel up to 5% away from the work location, potentially including overnight or weekend travel.
• Ability to meet applicable PPE requirements and perform role-related physical activities, including lifting up to 40 pounds, with or without reasonable accommodation.
• Authorization to work in the United States without sponsorship.

Nice To Haves

• At least 2 years of experience in biotechnology manufacturing, preferably in a GMP and/or ISO 13485 environment.

Responsibilities

• Partner with Operations as a Quality representative to review production records, executed test methods, and material disposition decisions before commercial distribution.
• Review process and test method validation, equipment and facility qualification documentation, and calibration records; identify and resolve deficiencies before commercial use.
• Support nonconformance and deviation investigations, assess process risks, recommend mitigations, and help improve manufacturing and quality processes.
• Review and approve standard operating procedures and manufacturing work instructions.
• Conduct production-area audits to maintain compliance with cGMP, ISO, ICH, and internal quality standards.
• Collaborate with cross-functional teams to resolve day-to-day quality concerns, maintain accurate documentation, and support continuous improvement.

Benefits

• Career development opportunities with an international company.
• Employees may qualify for free medical coverage in the Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• Retirement savings plan with a high employer contribution.
• Tuition reimbursement.
• Freedom 2 Save student debt program.
• FreeU education benefit, an affordable and convenient path to earning a bachelor’s degree.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level