Software Quality Engineer I

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.

     

JOB DESCRIPTION:

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re 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. 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 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 around the world and named one of the most admired companies in the world by Fortune.

The Opportunity

This position works out of our Sylmar, CA location in the Cardiac Rhythm Management division.

As a global leader in Cardiac Rhythm Technologies, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats.

We are seeking a high caliber Software Quality Engineer I. This position is responsible for executing and maintaining quality engineering methodologies and providing quality engineering support for software. Ensures software systems are developed, validated and maintained in compliance with regulatory and business procedures. Work requires the application of theoretical engineering principles, evaluation, ingenuity and creative/analytical techniques typically acquired in a recognized four-year or more academic course of specialized study. Applies engineering and scientific principles to the evaluation and solution of technical problems in a creative manner unique to each project. Exercises level appropriate technical judgment in planning, organizing, performing, and/or coordinating engineering work.

What You’ll Work On

• Work with Design and Manufacturing Engineering in the completion of system/software requirements and other verification and validation processes.

• Create and execute or direct software validation protocols and reports traceable to system/software requirements. Execute and support on-time completion of Quality Engineering deliverables: test plans (manual and automated), test scripts (manual and automated), test reports.

• Review and approve Non-Product Software (NPS) assessment, Data Integrity assessments and Risk Analysis assessment to comply with FDA 21 CFR Part 11.

• Participate in reviews for Software requirements with ability to interpret and review system design (hardware, firmware, software) and provide useful feedback.

• Implement solutions for controlling code and administer Code Control and Software Event/Defect Tracking software systems.

• Assist in the completion and maintenance of risk analysis, focused on software related risks.

• Support cybersecurity assessments with cross functional team

• Follow approved Design Control procedures for software development in accordance with FDA guidelines.

• Contributes to and supports a variety of test phase efforts.

• Support the establishment of objective, measurable, and verifiable customer and product requirements

• Reviews project deliverables such as specifications, code, and test/tool procedures for feasibility, thoroughness, clarity, correctness, and accuracy.

• Bring forth ideas and implement quality tools that improve the software design reviews and software testing lifecycle

• Apply quality principles, analyzes quality records, prepares reports and recommends improvements.

• Support all Company initiatives as identified b