Software Quality Engineer - Nutrition - Columbus OH/Abbott Park, IL

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.

Software Quality Engineer

Nourish the world and your career as part of the Nutrition team at Abbott.

Our Nutrition business develops science-based nutrition products for people of all ages, from helping babies and children grow, to keeping adult bodies strong and active. Millions of people around the world count on our leading brands - including Similac®, PediaSure®, Pedialyte®, Ensure®, Glucerna® and ZonePerfect® - to help get the nutrients they need to live their healthiest life.

The Software Quality Engineer will provide validation support, consultation, and training to both internal and external software development providers to assure standards are established and maintained for all phases of the computerized system lifecycle. This position will also interface with SMEs to capture and share best practices globally


Core Job Responsibilities:
  • Manage software compliance related project as needed
  • Lead software quality assurance validation efforts and system compliance to federal regulations (e.g. 21 CFR Part 11, cGMP etc) and set overall strategic vision for sites and providers.
  • Provide validation training and consultation services on validation policies and practices.
  • Provide guidance on defining thevalidation & verification strategy, including risk management mitigations, verification and validation plans, protocols, and reports.
  • Review, analyze and provide recommendations for verification and validation test data.
  • Provide guidance on resolving deviations associated with verification and validation activities.
  • Responsible for ongoing support of M-files Validation Management System.
  • Provides the business with consistent guidance in the creation, interpretation, and implementation of software quality systems. Assures consistent interpretation and implementation of regulatory requirements and software process improvement initiatives for the business.
  • Promote continuous process improvements by initiating and supporting process improvements to reduce software validation costs and cycle time.
  • Develop and track validation related metrics.
  • This position does not have direct reports but requires skills in influencing others without direct reporting relationships.


  • B.S. degree in engineering, science, or technical related field.

  • 3+ years of experience in design/process verification and validation in a regulated environment such as Medical Devices, Pharmaceutical Products or Food Manufacturing desired.
  • Knowledgeable in statistical rationale and sampling plans.
  • Experience creating software verification and validation strategy,plans, protocols, and reports.
  • Understanding of engineering best practices and test methodologies.
  • Demonstrated capability to solve technical problems.
  • Strong verbal and written communication skills.
  • A high degree of interpersonal relationsskills .
  • Able to work independently and/or function with minimal super vision. Must be able to work under pressure and stress common to office environments.
  • Must be able to maintain a high degree of accuracy and analytical thinking.
  • Must be able to deal effectively with problems and internal customers.
  • Must have knowledge of Microsoft Office Suite.

    Misc: Travel 15%


    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.

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