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Principal Quality Assurance Engineer

2 months ago

Irving, United States Abbott Laboratories Full time

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 114,000 colleagues serve people in more than 160 countries.

Principal Quality Assurance Engineer

About Abbott

Abbott is a global healthcare leader, creating breakthrough science to improve peopleâs health. Weâre 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. Youâll 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 bachelorâs 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 Dallas, TX location in the Transfusion Medicine Division. Our diagnostic solutions are used in hospitals, laboratories, and clinics around the globe. The crucial information derived from our tests, instruments and informatics systems are often the first step in patient care decision making for hundreds of health conditions from heart attacks to blood disorders to infectious diseases and cancers.

As the Principal Quality Assurance Engineer, youâll be responsible for developing and maintaining quality engineering methodologies and providing quality engineering support within several areas of the Quality System, including Operations, Data Analytics, and Continuous Improvement. This position represents the voice of Quality to lead and execute complex projects that drive continuous improvement, and ensures compliance with regulatory, customer, and internal requirements. The Principal QA Engineer is a member of the Dallas TM QA Leadership Team, responsible to ensure site accountability for the governance of the Site quality management system, product acceptance, and product quality.

What Youâll Work On

  • Represents Dallas Transfusion Medicine (TM) Quality Assurance (QA) while on cross-functional project teams with other functional leaders.

  • Be innovative, resourceful, and work with minimal direction. Have excellent organization, problem solving, communication, and team leadership skills. Work effectively with cross-functional teams.

  • Lead, coach, and mentor junior engineers.

  • May provide oversight to one or more QA professionals and/or contractors.

  • Provide Quality Engineering Body of Knowledge guidance and leadership to department and organization.

  • Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.

  • Makes independent decisions within defined parameters while assuring that these decisions are compliant with site level policies and procedures and are aligned with the appropriate quality system.

  • Documentation & Change Control - Formulates thorough reason and justification for change.

  • Represent Dallas TM as a SME in multiple quality subsystems, divisional process communities, and/or quality system audits.

  • Quality Engineering - Applies advanced knowledge of ISO 13485, MDSAP, and GMP/GDP requirements elements from product inception through launch and manufacturing.

Required Qualifications

  • Bachelors Degree

  • Minimum 5 years of experience, 5-7 years of relevant experience in Quality Assurance and / or Manufacturing and / or Engineering.

Preferred Qualifications

  • Basic HACCP Certification, Preventive Controls Qualified Individual (PCQI) Certified preferred, and Safe Quality Food (SQF) Practitioner preferred.

  • Industry certification or advanced degree preferred.

  • Minimum 8 years in Class III or II medical device experience. Roles of increasing responsibility, impact, and scope within a manufacturing support environment in quality desired.

  • Demonstrated and impactful strong project management and people leadership skills required.

  • Ability to work effectively and deliver results within a team, and in a fast-paced changing environment.

  • Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.

  • Ability to travel approximately 25%, including internationally (if required).

* 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.



The base pay for this position is $95,000.00 â $190,000.00. In specific locations, the pay range may vary from the range posted.