Software Development Quality Engineer II

Abbott (abbottcareers2 board); United States; On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Free HIP medical plan

Excellent retirement plan with high ER

Tuition reimbursement

FreeU education benefit

Job summary

Abbott in Sylmar, CA is seeking a Quality Engineer to execute and maintain quality engineering methodologies and provide QA support for software used across the division. The role is onsite and focused on ensuring compliance with regulatory requirements.

You will plan, execute, and lead test plans and reports, drive V&V activities, develop SOPs, and participate in design reviews and audits to improve the software and firmware testing lifecycle.

Qualifications

• Experience applying quality engineering methodologies to software.
• Ability to plan, execute, and document QA deliverables on schedule.
• Familiarity with FDA regulatory requirements is a plus.

Responsibilities

• Plan, execute, and complete QA deliverables including test plans, procedures, scripts, and reports.
• Lead test planning and execution with cross-functional teams.
• Develop and maintain SOPs and test procedures per Quality System requirements.
• Perform Design Verification and Validation activities and drive issue resolution.
• Participate in requirements reviews, design reviews, and code inspections.

Skills

Quality Engineering

Test planning

Test automation

Regulatory compliance

V&V

SOP development

Code inspections

Tools

Test automation tools

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.

JOB DESCRIPTION: 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.

MAIN PURPOSE OF THE ROLE

This role is ONSITE and is based out of the Sylmar, CA location.

This position is responsible for executing and maintaining quality engineering methodologies and providing quality engineering support for software utilized throughout division.

MAIN RESPONSIBILITIES

What You'll Do

• Plan, execute, and complete Quality Engineering deliverables on schedule, including manual and automated test plans, test procedures, scripts, and reports.
• Lead and coordinate test planning and execution activities, ensuring alignment with project schedules and cross-functional dependencies.
• Acquire and apply a strong understanding of testing methodologies, processes, tools, templates, and test environments to effectively support assigned projects.
• Clearly communicate and support team members and cross-functional partners in understanding testing strategies, processes, tools, and quality concepts.
• Develop, review, and maintain standard operating procedures (SOPs), specifications, and test procedures in accordance with Quality System requirements.
• Execute Design Verification and Validation (V&V) activities, including hands‑on testing, test automation development as appropriate, and cross-functional root‑cause analysis and issue resolution.
• Participate in and provide quality input during system, software, and firmware requirements reviews, design reviews, and code inspections, leveraging static analysis and test‑driven development (TDD) practices as applicable.
• Review and assess test protocols, procedures, and test results generated by other functional groups to ensure accuracy, completeness, and compliance.
• Support product Risk Management activities, including identification, assessment, and verification of software‑related risk controls.
• Proactively identify opportunities to improve software and firmware design reviews through enhanced quality tools, checklists, and review practices.
• Drive continuous improvement of the software and firmware testing lifecycle through the introduction and adoption of effective tools, automation, and best practices.
• Ensure Design History File (DHF) content is complete, accurate, traceable, and compliant with applicable regulatory and standards requirements, and collaborate to resolve gaps.
• Support internal and external audits, inspections, and associated responses, including preparation and resolution of observations.
• Support the definition and verification of objective, measurable, and verifiable customer and product requirements.
• Review and approve Document Change Requests in a timely, thorough, and objective manner.
• 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) regulation