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 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.

MAIN PURPOSE OF ROLE

This is an ONSITE role based out of Sylmar, CA

The Software Quality Engineer I provides design quality engineering support for the development and maintenance of mobile medical device software applications and connected digital health solutions. This role partners closely with software development, systems engineering, cybersecurity, product management, clinical, and regulatory teams to ensure software products are developed in accordance with applicable quality system regulations, industry standards, and company procedures. The position will primarily support native mobile applications (iOS and Android), cloud-connected healthcare solutions, and related software systems.

What You’ll Do

• Support design quality activities throughout the software development lifecycle, including requirements reviews, risk management, software verification and validation, traceability assessment, cybersecurity assessments and defect management.
• Review software lifecycle deliverables, participate in design and release reviews, and ensure software development activities align with Design Control requirements, software lifecycle standards, and risk management processes.
• Support software risk management activities in accordance with ISO 14971 and internal procedures.
• Evaluate software defects and assess potential product quality impacts.
• Participate in investigation and resolution of software-related quality issues.
• Gain familiarity with testing methodology, processes, tools, templates, environment, and work with cross functional teams to complete tasks assigned
• Review system, integration, regression, usability, and mobile application testing verification strategies, protocols, reports, and test evidence. Review test coverage to ensure adequate verification of requirements and risk controls.
• Complete Document Change Request Reviews in a timely and objective manner
• Drive continuous improvement activities and support investigations, CAPAs, and compliance initiatives related to software products and processes.
• Support preparation and maintenance of Design History File (DHF) and software lifecycle documentation.
• Support internal & external audit and related responses
• Additional duties may be identified by functional management based on the current project/business objectives.
• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
• Performs other related duties and responsibilities, on occasion, as assigned.

EDUCATION AND EXPERIENCE YOU’LL BRING

• Bachelor level degree in Computer science, software engineering or a closely related discipline or an equivalent combination of education and work experience.
• Minimum 2-5+ years of combined experience in software quality, software development, software verification and validation, software testing, or related engineering role.
• Understanding of software development lifecycle methodologies including Agile development practices.
• Fundamental understanding of software engineering principles and quality systems.
• Programming experience in C/C#/Visual Studio/Java, Scripting Language such as Python, Ruby, Perl
• Experience with software configuration, and issue tracking tools such as GIT, Jira, Azure DevOps, ClearQuest, DOORS.

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