Quality Assurance Engineer

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 122000 colleagues serve people in more than 160 countries.

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. Youll 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 bachelors 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 Youll 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

• Bachelors 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 bachelors 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: 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.

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The base pay for this position is

$61300.00 $122700.00

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

Quality Assurance

ONCO Cancer Diagnostics

United States > Madison : 1 Exact Lane

Standard

No

No

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 of Minorities/Women/Individuals with Disabilities/Protected Veterans.

EEO is the Law link - English: EEO is the Law link - Espanol: Experience:

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