Senior Quality Assurance Engineer – Non-Product Software Validation

Regulatory Jobs; Irving (TX); On-site; USD 78,000 - 156,000; Full time

Job summary

Abbott is seeking a Senior Quality Assurance Engineer for Non-Product Software Validation at the Irving, TX site in the Transfusion Medicine diagnostics division. You will apply software quality engineering principles to ensure lifecycle compliance and improve development efficiency across ADD.

You will implement and maintain quality systems, investigate quality problems, support risk assessments, and contribute to validation packages while ensuring FDA QSR, ISO, and 21 CFR Part 11 compliance.

Qualifications

• Bachelor's degree in computer science, software engineering, or a closely related discipline; 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.

Responsibilities

• Implement and maintain the effectiveness of the quality system.
• Apply established software quality and engineering methods to investigate and solve software quality problems.
• Advise project management and participate in the quality aspects of software projects.
• Help 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.
• Deal with mid-level management and outside entities in response to quality problems, needed process improvement, and audit observations
• Review pre-defined deliverables/activities as identified in SWQA processes
• Apply basic risk management principles to all activities and tasks to investigate non-conformances
• Participate in development or modification of validation packages and deliverables (assessments, plans, requirements, protocols)
• Ensure compliance with FDA QSR, ISO guidelines, including 21 CFR Part 11 and Abbott Corporate requirements for computerized systems
• Assist with supplier assessments and evaluations to ensure products/services meet quality requirements.

Skills

Quality engineering

Software testing

Regulatory compliance

Risk management

Quality systems

Education

Bachelor's in CS/SE

Master's degree preferred

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.

JOB DESCRIPTION:

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. You’ll also have access to:

• 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.

The 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.

The Senior Quality Assurance Engineer, Non-Product Software Validation, is responsible for compliance with the non-product software Life Cycle supporting applications used throughout ADD. Uses software quality engineering principles to recommend unique tailoring approaches to allow the project to both meet its Software Life Cycle requirements and improve its development efficiency.

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.

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: https://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 abbott.com, on LinkedIn at https://www.linkedin.com/company/abbott-/, and on Facebook at https://www.facebook.com/AbbottCareers.

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

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 of Minorities/Women/Individuals with Disabilities/Protected Veterans.EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdfEEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf