About the position
The Sr. Software QA Engineer will be responsible (but not limited to) the following: Participate as a lead member of the Non-Product Software Quality Assurance (SWQA) team for Abbott Diabetes Care. Ensure applications that support the Quality Management System and validation/verification activities for consumer products are developed, validated, and maintained in compliance with regulatory, corporate and divisional requirements. Review quality system documentation products as they apply to the development, verification, validation, use, and maintenance of medical device software/systems in support of the Quality system. Coordinate activities with other engineering disciplines, departments, and contractors. This position is based out of our Alameda, CA location and will require being onsite Monday-Friday.
Responsibilities
- Completes software quality tasks in accordance with current Quality System Requirements.
- Works independently with objectives given by SWQA Manager.
- Can plan and coordinate own work according to higher-level project schedules.
- Reviews and provides lead guidance to the team regarding deliverables/activities as identified in project plans or equivalent documentation.
- Reports unexpected events, issues or software bugs which occur during verification/validation to project team and management.
- Coordinates the development and maintenance of departmental operating procedures to ensure compliance to relevant FDA, QSR, ISO guidelines.
- Software Quality lead in various phases of the development lifecycle.
- Maintains schedule and drive to meet project schedule as aligned with project(s) goals.
- Will also estimate, plan, schedule and review own and others' work products and be accountable for the quality of those reviews and delivery on schedule.
- Considered Non-Product SWQA compliance SME in support of external/internal audits.
Requirements
- Bachelor's degree, or equivalent experience, in a scientific, technical, or engineering discipline.
- 5 to 8 years' experience in Software Quality Assurance and/or Software Testing experience.
- Knowledge of FDA QSR, relevant ISO guidelines and 21 CFR Part 11.
- Must have 2 - 4 years project experience in software testing practices, methodologies including Agile and techniques, preferably in testing medical devices.
- Must have excellent oral and written communication skills.
Nice-to-haves
- ASQ Certifications a plus.
- Experience in working in a regulated environment strongly preferred.
- Cybersecurity, familiarity in AI, and cloud computing experience preferred.
Benefits
- Career development with an international company.
- Free medical coverage for employees via the Health Investment Plan (HIP) PPO.
- An excellent retirement savings plan with high employer contribution.
- Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit.
- A company recognized as a great place to work in dozens of countries.
- A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity.
