Quality Engineer II @ Abbott Laboratories - Irvine, CA

Job Overview

a month ago

Quality Engineer II

Abbott Laboratories - Irvine, CA

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 113,000 colleagues serve people in more than 160 countries.

About Abbott

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and 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.
  • Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
  • An excellent retirement savings plan with 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 around the world and named one of the most admired companies in the world by Fortune.
  • A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

This position works out of our Irvine, CA location in the Electrophysiology division. In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives.

As the Quality Engineer II, you'll have the chance to assure products, processes, and quality records conform to quality standards and establish compliance within Abbott's quality system. You will be responsible for maintaining a strong collaborative partnership with multi-functional teams, helping facilitate success by protecting patient safety and meeting business needs. You will be involved in nonconformance and complaint investigation management, including root cause problem solving and providing event information to our various business partners (e.g. Regulatory, Quality Engineering).

What You’ll Work On

  • Follows all regulations and standards for quality, Environmental, Health, Safety, and Energy (EHS&E) Global Policies, Abbott engineering standards, and other governance areas as applicable.
  • Implements and maintains the effectiveness of the Quality System.
  • Identifies areas of risk with respect to compliance to internal and external requirements.
  • Completes Non-conformance, CAPA, and complaint investigations and offers multiple solutions to issues with clear advantages and disadvantages.
  • Influences key partners to develop and maintain QA procedures, forms, and systems.
  • Leads meetings and communications for QA system information, concerns, and updates.
  • Help drive standard methodologies for data trending and tracking and identification of manufacturing related complaints in alignment with Abbott goals.
  • Follows U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
  • Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
  • Performs other related duties and responsibilities, on occasion, as assigned.


Required Qualifications

  • Bachelor level degree in Engineering, Technical Field, or equivalent
  • 2-5 years technical experience
  • Previous Quality assurance/engineering experience and use of Quality tools/methodologies
  • Advanced computer skills, including statistical/data analysis and report writing skills
  • Ability to work within a team and as an individual contributor in a dynamic, changing environment.
  • Strong verbal and written communication skills with ability to effectively communicate at multiple levels in the organization.
  • Multitasks, prioritizes and meets deadlines in timely manner.
  • Excellent organizational and follow-up skills, as well as attention to detail.

Preferred Qualifications

  • Detailed knowledge of FDA, GMP, and ISO 13485 preferred
  • ASQ CQT, CQE, CQA certification preferred
  • Six Sigma root cause analysis/problem solving training and experience preferred.

Apply Now

  • Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.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 www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

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

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 www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

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