Software Development Quality Engineer II

Abbott Laboratories; Los Angeles (CA); On-site; USD 82,000 - 141,000; Full time

Benefits offered by this job

Free medical coverage

High employer retirement contribution

Tuition reimbursement

FreeU education benefit

Global company with opportunities

Job summary

Abbott Laboratories in Sylmar, CA is seeking a Quality Engineer to execute and maintain quality engineering methodologies for software across the division. You will lead test planning, execute verification activities, and ensure SOPs and DHF compliance in a fast-paced, matrixed environment.

Qualified candidates typically hold a Bachelor's in Engineering and have 2+ years in software development or embedded systems, plus 2–5+ years in software testing/verification.

Qualifications

• Bachelor’s Degree in Engineering or Technical Field (or equivalent experience).
• 2+ years combined experience in software development and/or embedded systems.
• 2–5+ years combined experience in software testing and verification/validation.
• Experience with one or more: C, C++, C#, Python, Java, Visual Studio.
• Experience with Git, Jira, Subversion, DOORS, Bugzilla, or equivalent.
• Experience with code review and static analysis tools to support quality assessments.
• Experience with Agile or iterative SDLC programs.
• Knowledge of FDA, GMP, ISO13485 and related regulatory requirements.

Responsibilities

• Plan, execute, and complete Quality Engineering deliverables on schedule (manual and automated tests).
• Lead and coordinate test planning and execution with cross-functional partners.
• Apply testing methodologies, tools, environments to support projects.
• Communicate testing strategies and quality concepts across teams.
• Develop and maintain SOPs, specs, and test procedures per QMS requirements.
• Perform Design Verification and Validation activities including test automation as appropriate.
• Participate in requirements reviews, design reviews and code inspections with QA input.
• Review test protocols and results for accuracy and completeness.
• Support product risk management activities and risk controls verification.
• Drive continuous improvement of testing lifecycle with tools and best practices.

Skills

C/C++

Python

Java

Test automation

Agile SDLC

Communication

Education

Bachelor's Degree in Engineering

Tools

Git

Jira

Subversion

DOORS

Bugzilla

Code review tools

Job description

About Abbott

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 115,000 colleagues serve people in more than 160countries.

Work Benefits

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 2Save 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.

Role Purpose

Thisrole is ONSITE and isbased 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

• 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) 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.
• Perform other related duties and responsibilities on occasion, as assigned.

Qualifications

• Education: Bachelor’s Degree (±16years) in an Engineering or Technical Field (OR) an equivalent combination of education and work experience.
• Minimum 2years of combined experience in software development and/or embedded systems applications.
• 2–5+years of combined experience in software testing and verification/validation.
• Programming experience in one or more of the following languages or environments: C, C++, C#, Python, Java, Visual Studio, etc.
• Experience using software configuration management and defect tracking tools such as Git, Jira, Subversion, ClearQuest, DOORS, Bugzilla, or equivalent.
• Experience with code review and static analysis tools (e.g., Code Collaborator, Coverity, Parasoft DTP) to support software and firmware quality assessments.
• Experience working as a team member in Agile or iterative software development lifecycle (SDLC) programs.
• Working knowledge of multiple software and test lifecycles, including V‑Model, Iterative, and Agile/Scrum methodologies.
• Experience supporting automated test execution and coordination.
• Ability to work effectively in a highly matrixed and geographically diverse environment.
• Ability to contribute both as an individual contributor and as an effective team member in a fast‑paced, changing environment.
• Demonstrated ability to influence and collaborate with cross‑functional partners to accomplish project objectives.
• Strong verbal and written communication skills, with the ability to communicate effectively at multiple levels within the organization.
• Proven ability to prioritize, multitask, and meet deadlines in a dynamic work environment.
• Strong organizational, follow‑up and attention‑to‑detail skills.
• Detailed knowledge of FDA, GMP, IEEE1012 and ISO13485.
• Advanced computer skills, including statistical/data analysis and report writing.
• Advanced Information Technology and data mining skills.
• Prior medical device experience preferred.
• ASQ CSQE certification desired.
• Experience working in a broader enterprise/cross‑division business unit model preferred.
• Ability to leverage and/or engage others to accomplish projects.

Compensation and Perks

• The base pay for this position is$81,500.00 – $141,300.00. In specific locations, the pay range may vary from the range posted.
• Location: United States > Sylmar : 15900 Valley View Court
• Work shift: Standard
• Travel: Yes, 5 % of the Time
• Medical surveillance: Not Applicable
• Significant work activities: 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)
• Onsite

Equal Opportunity

Abbott is an Equal Opportunity Employer, committed to employee diversity.

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf

EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf

Company Culture

Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next‑generation diagnostics, life‑changing devices, science‑based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health.

Contact

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.