Senior Quality Assurance Engineer – Non-Product Software Validation

Thornton Tomasetti; Irving (TX); On-site; USD 78,000 - 156,000; Full time

Benefits offered by this job

Career development

Free medical coverage in HIP PPO

Excellent retirement savings plan

Tuition reimbursement

Diversity and inclusion recognition

Job summary

Abbott in Irving, TX is seeking a Quality/Software Quality Engineer to implement and maintain the quality system across software projects. You will apply QA methodologies, advise on project quality, and help improve SOPs.

FDA/ISO compliance is required, with opportunities to lead validation and risk assessments. The role offers growth in a global health-tech environment, with a competitive salary and comprehensive benefits.

Qualifications

• Bachelor’s degree in computer science, software engineering, or a closely related discipline. Master’s degree preferred.

Responsibilities

• Implement and maintain the effectiveness of the quality system.
• Apply established software quality methods to investigate and solve quality problems.
• Advise project management and participate in software project quality aspects.
• Develop and improve software development and quality SOPs.
• Lead in creating and improving software development and quality SOPs where needed.
• Interact with mid-level management and external entities regarding quality issues and process improvements.
• Review deliverables as identified in SWQA processes and project plans.
• Apply risk management principles to investigate non-conformances.
• Identify areas for process improvement and provide justification.
• Contribute to validation packages and deliverables, including risk assessments and protocols.
• Ensure compliance with FDA QSR, ISO guidelines, and 21 CFR Part 11.

Skills

Quality engineering

Regulatory compliance

Software testing

Education

Bachelor's Degree in Computer science or software engineering

Master’s degree preferred

Tools

QA methodologies

Job description

JOB DESCRIPTION

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 122,000 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.

Benefits

• 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 bachelor’s 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 that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.

Opportunity

This position works out of our Irving, TX location in the Transfusion Medicine, Diagnostics Division. 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.

What You’ll Work On

• Responsible for implementing and maintaining the effectiveness of the quality system.
• Apply established software quality and engineering methods to the investigation and solution of software quality problems.
• Advises project management and participates in the quality aspects of software projects.
• Helps in the creation and improvement of software development and quality operating procedures.
• May lead in the creation and improvement of software development and quality operating procedures.
• Deals with mid-level management and outside entities in response to quality problems, needed process improvement, and audit observations.
• Reviews pre-defined deliverables/activities as identified in software quality assurance (SWQA) Non-Product Quality Process and/or SWQA Product Quality Process/project plan or equivalent project plan.
• Apply basic risk management principles to all activities and tasks to investigate non-conformances.
• Identifies areas for process improvement and provides supporting information for change, including reasons and justifications.
• Participates in the development or modification of validation packages and deliverables, including assessments (including risk assessments, e.g., FMEAs), plans, requirements, and protocols.
• Ensure compliance with relevant FDA QSR, ISO guidelines, including 21 CFR Part 11 and Abbott Corporate requirements as they relate to the development, validation and maintenance of computerized systems.
• Assists with supplier assessments and evaluations to ensure products and services meet quality requirements.
• May evaluate vendor capabilities to provide required products or services.

Required Qualifications

• Bachelors Degree in Computer science, software engineering, or a closely related discipline or an equivalent combination of education and work experience.
• Master’s degree preferred.
• Minimum 4 years related work experience in Quality or a related field.
• Knowledgeable of FDA, Quality System Regulations (QSR), Medical Device Directive, ISO guidelines and 21 CFR Part 11.

Preferred Qualifications

• Project experience in software testing practices, methodologies and techniques, particularly in testing medical devices or experience leading test engineer team is a plus.

The base pay for this position is $78,000.00 - $156,000.00. In specific locations, the pay range may vary from the range posted.

JOB FAMILY: Operations Quality

DIVISION: TM Transfusion Medicine

LOCATION: United States > Irving : LC-02

ADDITIONAL LOCATIONS:

WORK SHIFT: Standard

TRAVEL: Yes, 5 % of the Time

MEDICAL SURVEILLANCE: Not Applicable

SIGNIFICANT WORK ACTIVITIES: 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, committed to employee diversity.

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential - because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions - across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health.

The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges. We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.