Senior Quality Assurance Engineer – Non-Product Software Validation

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 122000 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. Youll 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 bachelors 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. Were 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 Abbotts 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 Youll Work On

• Provide independent QA oversight for the computerized system validation (CSV) lifecycle from system implementation through retirement
• Review and approve Data Integrity Assessments and ensure compliance with ALCOA principles.
• Apply established software quality and engineering methods to the investigation and solution of software quality problems.
• Deals with mid-level management and outside entities in response to quality problems needed process improvement and audit observations.
• Review and approve validation deliverables including Validation Plans User Requirements Specifications (URS) Functional and Design Specifications Risk Assessments Traceability Matrices IQ/OQ/PQ protocols validation summary reports and periodic review documentation.
• 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.
• Assess and mitigate compliance risks related to electronic records electronic signatures data integrity cybersecurity and computerized systems.
• 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 GAMP 5 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. Masters 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: 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.

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The base pay for this position is

$78000.00 $156000.00

In specific locations the pay range may vary from the range posted.

Operations Quality

TM Transfusion Medicine

United States > Irving : LC-02

Standard

Yes 5 % of the Time

Not Applicable

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: EEO is the Law link - Espanol: Experience:

Senior IC