Quality Assurance Engineer

Abbott (abbottcareers2 board); Madison (WI); On-site; USD 85,000 - 110,000; Full time

Job summary

Abbott in Wisconsin seeks a Quality Assurance Engineer to partner with Operations in the Cancer Diagnostics group. You will oversee quality systems and ensure equipment, processes, and facilities meet regulatory standards.

The role includes qualification, validation, risk management, investigations, change control, and continuous improvement to sustain product quality. Travel up to 15% may be required.

Qualifications

• Bachelor's degree in a science or technical field required.
• Three+ years in a manufacturing operations environment.
• One+ years applying quality principles in an area such as Design Transfer, Risk Management, or Manufacturing Quality.
• One+ years of experience with process or test method validation, equipment qualification, or related quality engineering activities.
• Experience in FDA 21 CFR 820, ISO 13485, ISO 9001, and/or cGMP environments.
• Ability to travel up to 15% (overnight or weekend travel).

Responsibilities

• Provide Quality Engineering oversight of manufacturing processes, instruments, equipment, facilities, utilities, and automated systems across lifecycle.
• Review changes for potential impacts to product quality, process performance, equipment qualification, validated state, and regulatory compliance.
• Lead or support investigations involving deviations, nonconformances, out-of-spec results, equipment failures, calibration issues, and monitoring excursions.
• Support CAPA to address quality issues and drive sustainable improvements.
• Provide Quality Engineering oversight of design and technology transfer activities, including qualification, validation, and risk management.
• Partner with engineering and operations to evaluate process improvements and equipment changes.
• Review and approve Quality Management System records, engineering docs, qualification/validation records, investigations, and change controls.
• Exercise independent Quality Engineering judgment to identify compliance risks and actions.

Skills

Quality engineering

FDA 21 CFR 820

ISO 13485

cGMP

Risk management

CAPA

Process validation

Manufacturing quality

Travel 15%

Education

Bachelor's degree in science or technical field

Associate degree + 2 years relevant experience

Job description

Working at Abbott

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.

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.

• 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 Qual