Software Quality Engineer I

Abbott • Los Angeles, CA

2d • $73,900 - $116,000 • Onsite

About The Position

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. The role partners with software development, systems engineering, cybersecurity, product management, clinical, and regulatory teams to ensure software products meet applicable quality system regulations, industry standards, and company procedures. The position primarily supports native iOS and Android applications, cloud-connected healthcare solutions, and related software systems. This is an onsite position based in Sylmar, California, with travel listed as 10% of the time.

The engineer supports design quality across the software development lifecycle, including requirements reviews, risk management, verification and validation, traceability assessment, cybersecurity assessments, and defect management. The role also reviews lifecycle documentation and testing evidence, supports quality issue investigations and corrective actions, and contributes to audit readiness, design history files, and continuous improvement. The position requires a bachelor's-level degree in computer science, software engineering, or a closely related discipline, or an equivalent combination of education and work experience, and 2–5+ years of combined relevant experience.

Requirements

• Bachelor's-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 a related engineering role.
• Understanding of software development lifecycle methodologies, including Agile practices.
• Fundamental understanding of software engineering principles and quality systems.
• Programming experience in C, C#, Visual Studio, or Java, and a scripting language such as Python, Ruby, or Perl.
• Experience with software configuration and issue-tracking tools such as Git, Jira, Azure DevOps, ClearQuest, or DOORS.
• Experience with test automation and analysis tools such as Selenium, Appium, Postman, or API testing tools.
• Strong analytical and problem-solving skills.
• Ability to work both as part of a team and as an individual contributor in a fast-paced, changing environment.
• Ability to leverage or engage others to accomplish projects.
• Strong verbal and written communication skills and ability to communicate effectively at multiple organizational levels.
• Ability to multitask, prioritize, and meet deadlines in a timely manner.
• Strong organizational and follow-up skills, with attention to detail.

Nice To Haves

• Experience supporting the development and deployment of mobile applications for iOS and Android.
• Experience in a regulated industry such as medical devices, healthcare, pharmaceuticals, aerospace, or automotive.
• Familiarity with medical device software standards, including IEC 62304, ISO 14971, IEC 62366, IEC 82304-1, and FDA Quality System requirements.
• Knowledge of mobile application architecture and development concepts.
• Experience reviewing software requirements, test protocols, and design documentation.
• Familiarity with software defect tracking and requirements management tools.
• Experience with cloud-connected, distributed, or client-server software systems.
• Understanding of cybersecurity principles and secure software development practices.

Responsibilities

• 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 and participate in design and release reviews to ensure alignment with Design Control requirements, software lifecycle standards, and risk management processes.
• Support software risk management in accordance with ISO 14971 and internal procedures.
• Evaluate software defects and assess potential product quality impacts.
• Participate in investigating and resolving software-related quality issues.
• Develop familiarity with testing methodologies, processes, tools, templates, and environments, and work with cross-functional teams to complete assigned tasks.
• Review system, integration, regression, usability, and mobile application testing strategies, protocols, reports, and evidence; assess test coverage for adequate verification of requirements and risk controls.
• Complete Document Change Request reviews in a timely and objective manner.
• Drive continuous improvement and support investigations, CAPAs, and compliance initiatives related to software products and processes.
• Support preparation and maintenance of the Design History File and software lifecycle documentation.
• Support internal and external audits and related responses.
• Support company initiatives and comply with Quality Management Systems, Environmental Management Systems, FDA regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments.
• Maintain positive and cooperative communication and collaboration with employees at all levels, customers, contractors, and vendors.
• Perform other related duties and responsibilities as assigned.

Benefits

• Potential eligibility for free medical coverage through the Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• Retirement savings plan with a high employer contribution.
• Tuition reimbursement.
• Freedom 2 Save student debt program.
• FreeU education benefit, offering an affordable and convenient path to a bachelor's degree.
• Career development opportunities with an international company.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level