Manufacturing Line Quality Engineer

Abbott Laboratories Westbrook , ME 04092

Posted 2 months ago

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 109,000 colleagues serve people in more than 160 countries.

Diagnostic testing is a compass, providing information that helps in the prevention, diagnosis and treatment of a range of health conditions.

Abbott's life-changing tests and diagnostic tools give you accurate, timely information to better manage your health. We're empowering smarter medical and economic decision making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott's diagnostics instruments, providing lab results for millions of people.

The position of Manufacturing Line Quality Engineer is within our Infectious Disease Developed Markets business unit located at Westbrook, Maine. In this role you will provide support for product quality assurance, process improvements and all quality system program at the Westbrook Site.


  • Support production with resolution of quality issues in accordance with established procedures.

  • Support production on the manufacturing floor, ensuring adherence to procedures and ensure appropriate device history record (DHR) documentation. Supports line clearances, reworks, and inspections as required.

  • Support the NC and CAPA processes by completing risk assessments, root cause investigations, and action plans.

  • Perform Risk Management activities using the Failure Mode and Effect Analysis methodology (e.g. dFMEA, pFMEA). Support peers in the development of mitigations for failure modes and verify the effectiveness of these mitigations.

  • Supports the change control process by reviewing proposed changes, performing risk assessments, and assessing the adequacy of verifications and validations.

  • Reviews qualifications, validations, and other studies for technical content, statistical and sampling rationale, unintended impact and clarity. Act as the Quality representative for qualification and validation approvals for all validated equipment.

  • May participate on design transfer and improvement project teams.

  • Demonstrates commitment to the development, implementation and effectiveness of Quality Management System per ISO, FDA, and other regulatory agencies.

  • Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company's policies and practices.

  • Understands and is aware of the quality consequences which may occur from the improper performance of their specific job. Has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities.

  • Other duties as assigned, according to the changing needs of the business.



  • Bachelor's Degree in Engineering, Chemistry, Biotechnology, Life Science or other technical field or the equivalent combination of education and experience.


  • 2-5 years' experience in the medical device or other regulated industry.

  • Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA) Certification


  • Knowledge of Agile program.

  • Working knowledge of Database software; Internet software; Inventory software; Spreadsheet software and Word Processing software.

  • Working knowledge of FDA, cGMPs/QSR and ISO quality system requirements

  • Strong technical writing skills and effective communication skills


At Abbott, you can have a good job that can grow into a great career. We offer:

  • Training and career development, with onboarding programs for new employees and tuition assistance

  • Financial security through competitive compensation, incentives and retirement plans

  • Health care and well-being programs including medical, dental, vision, wellness and occupational health programs

  • Paid time off

  • 401(k) retirement savings with a generous company match

  • The stability of a company with a record of strong financial performance and history of being actively involved in local communities

Learn more about our benefits that add real value to your life to help you live fully:

Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at, on Facebook at and on Twitter @AbbottNews and @AbbottGlobal.

An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities.

icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Automation Engineer

Vantage Point Recruiting

Posted 2 days ago

VIEW JOBS 10/26/2021 12:00:00 AM 2022-01-24T00:00 <p>Our client is a prominent figure in human health and innovation. Their Automation Engineer role supports product development from concept through sustained manufacturing of regulated products. Involved in process development, equipment acquisition, applying engineering principles assuring compliance, quality and safety standards.</p><ul><li>Process development, equipment specification, acquisition and implementation.</li><li>Evaluation of machine logic and controls to troubleshoot equipment and identify process improvement opportunities.</li><li>Integration of controls hardware and software into new and existing manufacturing equipment.</li><li>Design of experiments, validation, completion of testing and analysis of data.</li><li>Suggests and supports new methods or materials for continual improvement of quality and efficiency.</li><li>Analyzes current equipment for process suitability and provides detailed plans for improvement</li></ul><p>Education &amp; Experience:</p><ul><li>Bachelor's degree (BS) in engineering or equivalent combination of education and experience.</li><li>At least 1 year engineering experience in a manufacturing environment</li><li>Experience working in an ISO regulated environment</li><li>Previous experience with common manufacturing automation technologies and architectures is required</li></ul><p>e.g: Programmable Logic Controllers (PLC&rsquo;s) (Allen Bradley Logix5000 experience preferred)</p><ul><li>Ability to read and troubleshoot existing ladder logic.</li><li>Ability to generate new ladder logic for the sequencing of complex manufacturing tasks.</li></ul><p>Human Machine Interfaces (HMI) (Allen-Bradley Factory Talk View experience preferred)</p><ul><li>Ability to modify and troubleshoot existing user interfaces.</li><li>Ability to design and implement new user interface functionality.</li></ul><p>Motion Control to include Servo Drives, VFD&rsquo;s and Stepper Drives.</p><ul><li>Ability to troubleshoot and tune control loops.</li></ul><p>Robots (Staubli and/or Epson experience preferred)</p><ul><li>Ability to modify robot programs and taught positions.</li><li>Ability to sequence new robot paths and functions.</li></ul><p>Vision Systems (Cognex and/or Keyence experience preferred)</p><ul><li>Ability to troubleshoot existing vision inspection applications.</li><li>Ability to design new systems to include lens and lighting selection.</li><li>Ability to create robust inspection logic for the disposition of product.</li></ul><p>Electrical Aptitude</p><ul><li>Ability to read and trace machine control systems from electrical prints</li><li>Ability to troubleshoot common machine control hardware (relays, fuses, breakers, etc.)</li><li>Ability to generate and modify electrical prints to support controls upgrade and integration.</li></ul><p>Sponsorship and/or relocation assistance will be considered</p><ul><p>&nbsp;</p></ul> Vantage Point Recruiting Westbrook ME

Manufacturing Line Quality Engineer

Abbott Laboratories