Quality Assurance Engineer

Abbott; Madison (WI); On-site; USD 61,000 - 123,000; Full time

Job summary

Abbott in Madison, Wisconsin is seeking a Quality Assurance Engineer to provide quality oversight across manufacturing processes, equipment, and facilities within Cancer Diagnostics operations. You will work with cross-functional teams to ensure validated state, risk management, and CAPA-driven improvements in a regulated environment.

The role requires collaboration with Facilities, Metrology, Process and Controls Engineering, and Production teams to ensure product quality meets FDA/ISO

Qualifications

• Bachelor's degree in science or technical field; or an associate degree with 2 years of relevant experience.
• 3+ years in a manufacturing operations environment.
• 1+ years applying quality principles in Design Transfer, Risk Management, or Manufacturing Quality.
• 1+ years in process or test method validation, equipment qualification, or related quality engineering activities.
• Experience in FDA 21 CFR 820, ISO 13485, ISO 9001, or cGMP environments.
• Ability to travel up to 15% and work in the United States without sponsorship.

Responsibilities

• Provide Quality Engineering oversight of manufacturing processes, equipment, facilities, utilities, and automated systems, including qualification and validation.
• Review changes for potential impacts to product quality, process performance, equipment qualification, validated state, and regulatory compliance.
• Lead or support investigations involving deviations, nonconformances, calibration issues, and environmental monitoring excursions.
• Support risk assessments and CAPA to address quality issues and drive improvements.
• Provide oversight of design and technology transfer activities, including qualification, verification, validation, and manufacturing readiness.
• Collaborate with engineering and operations to evaluate process improvements and changes.
• Review and approve QMS records, documentation, investigations, and change controls for compliance.
• Apply independent Quality Engineering judgment on technical issues and compliance risks.

Skills

Quality Assurance

Process Validation

Risk Management

CAPA

Investigations

Regulatory Knowledge

Education

Bachelor's degree in science/technical field

Associate degree + 2 years experience in lieu of degree

Tools

eQMS

PLM

Equipment asset management

Job description

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.

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.

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.

JOB FAMILY: Quality Assurance DIVISION: ONCO Cancer Diagnostics LOCATION: United States > Madison : 1 Exact Lane ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: No MEDICAL SURVEILLANCE: No SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)

Abbott is an Equal Opportunity Employer, committed to employee diversity.

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf

EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf

Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health.