Quality Assurance Engineer

Abbott abbott.com Open

United States > Madison : 1 Exact Lane Full-time Mid-level QA & Test

At a glance

Mid-level QA & Test role at Abbott. United States > Madison : 1 Exact Lane · full-time · $61,300–$122,700 base.

SalaryStated by Abbott

$61,300 – $122,700

Base salary for this role, in USD per year, as published in the posting.

RoleQA & Test

SeniorityMid-level

LocationUnited States > Madison : 1 Exact Lane

EmploymentFull-time

Base pay$61,300–$122,700

PostedOct 20, 2026

Role brief

techroles summary, based on the employer's posting.

What you'll do

Guide quality controls for manufacturing equipment, facilities and automated systems from qualification through maintenance and improvement
Check proposed engineering and production changes for effects on product quality, process performance and regulatory compliance
Investigate production deviations, nonconforming results, equipment issues and monitoring excursions, either leading the work or supporting it
Assess quality risks, trace root causes and shape corrective actions that address problems and prevent recurrence
Review quality records and engineering files, while supporting product transfers, validation and operational improvements

What you bring

A science or technical bachelor’s degree, or an associate degree in that area plus two years of relevant experience
At least three years in a manufacturing operations setting
One year applying quality practices and one year handling validation, equipment qualification or similar quality engineering work
Experience in a setting governed by FDA, ISO or cGMP standards, plus U.S. work authorization without sponsorship

Who this fits

You’ll work with operations, engineering, manufacturing and quality teams supporting Cancer Diagnostics. The role suits someone prepared to make independent quality decisions and follow applicable PPE requirements. Travel can reach fifteen percent, including overnight or weekend trips. The position is in Madison, Wisconsin, and involves prolonged sitting and frequent keyboard use.

From the employer

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 122,000 colleagues serve people in more than 160 countries.

JOB DESCRIPTION:

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You'll also have access to:

Career development with an international company where you can grow the career you dream of.
Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
An excellent retirement savings plan with a high employer contribution.
Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor's degree.
A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
A company recognized as one of the best big companies to work for, as well as one of the best places to work for diversity, working mothers, female executives, and scientists.

The Opportunity

This position supports Operations within the Cancer Diagnostics business.

As a Quality Assurance Engineer, you will partner with Facilities, Service & Metrology, Process and Controls Engineering, Instrument Production, Reagent Manufacturing, Quality Control, and other areas of Operations. Depending on the assigned area, you will provide Quality oversight of products, materials, manufacturing and QC laboratory equipment and processes, instrumentation, facilities, utilities, and associated systems through qualification and validation, risk management, investigations, change control, and continuous improvement.

What You'll Work On

Provide Quality Engineering oversight of manufacturing processes, instruments, equipment, facilities, utilities, and automated systems throughout their lifecycle, including qualification, validation, maintenance, calibration, and continuous improvement activities.
Review and assess engineering and manufacturing changes for potential impacts to product quality, process performance, equipment qualification, validated state, and regulatory compliance.
Lead or support investigations involving manufacturing deviations, nonconformances, out-of-specification results, equipment failures, calibration issues, and process or environmental monitoring excursions.
Support risk assessments, support root-cause investigations, and develop or evaluate corrective and preventive actions (CAPA) to address quality issues and drive sustainable improvements.
Provide Quality Engineering oversight of design and technology transfer activities, including manufacturing readiness, equipment and process qualification, verification and validation, risk management, and implementation of new or modified products and processes into Operations.
Partner with engineering and operational teams to evaluate process improvements, equipment modifications, automation and control system changes, and manufacturing or QC testing requirements.
Review and approve applicable Quality Management System records, engineering documentation, qualification and validation records, investigations, and change controls to ensure compliance with established procedures and regulatory requirements.
Exercise independent Quality Engineering judgment when evaluating technical issues, identifying compliance risks, and recommending appropriate actions to maintain product quality and process control.

Required Qualifications

Bachelor's degree in a science or technical field; or an associate degree in a science or technical field plus two (2) years of relevant experience in lieu of a bachelor's degree.
Three (3) or more years of experience in a manufacturing operations environment.
One (1) or more years of experience applying quality principles and practices in an assigned area such as Design Transfer, Risk Management, or Manufacturing Quality.
One (1) or more years of experience with process or test method validation, equipment qualification, or related quality engineering activities
Demonstrated ability to work in an FDA 21 CFR 820, ISO 13485, ISO 9001, and/or cGMP-structured environment.
Ability to travel up to 15%, including possible overnight or weekend travel, and comply with applicable personal protective equipment requirements.
Authorization to work in the United States without sponsorship and ability to perform the essential duties with or without accommodation.

Preferred Qualifications

Three (3) or more years of experience in medical device, biotechnology, pharmaceutical, or other regulated manufacturing environments.
Experience supporting manufacturing processes, equipment, instrumentation, facilities, utilities, or Quality Control operations.
Knowledge of equipment qualification, process validation, test method validation, and associated risk management principles.
Experience supporting calibration, preventive maintenance, environmental monitoring, or equipment lifecycle management programs.
Familiarity with manufacturing automation, process controls, and computerized systems in regulated environments.
Experience supporting design and technology transfer activities, manufacturing process improvements, or implementation of new equipment and processes.
Experience with electronic Quality Management Systems (eQMS), Product Lifecycle Management (PLM), or equipment asset management systems.
Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or other relevant professional certification.

Apply Now

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: https://abbottbenefits.com/

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at abbott.com, on LinkedIn at https://www.linkedin.com/company/abbott-/, and on Facebook at https://www.facebook.com/AbbottCareers.

The base pay for this position is

$61,300.00 – $122,700.00

In specific locations, the pay range may vary from the range posted.