Senior Compliance Software Engineer (Product)

Abbott Laboratories-posted 3 months ago
$98,000 - $196,000/Yr
Full-time • Mid Level
Alameda, CA
Computer and Electronic Product Manufacturing
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The Sr. Compliance Software Engineer (Product) will be responsible (but not limited to) the following: Participates as a lead member of the Software Quality Assurance (SWQA) team for Abbott Diabetes Care products that ensures digital applications and firmware produced by ADC is 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. Coordinate activities with other engineering disciplines, departments, and contractors.

  • 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.
  • Assists subordinate staff in recognizing the same.
  • Coordinates the development and maintenance of departmental operating procedures to ensure compliance to relevant FDA, QSR, ISO guidelines, including 21 CFR Part 11 and Abbott Corporate requirements.
  • Maintains schedule and drive to meet project schedule as aligned with project(s) goals.
  • Estimates, plans, schedules and reviews own and others' work products and is accountable for the quality of those reviews and delivery on schedule.
  • Considered Non-Product SWQA compliance SME in support of external/internal audits.
  • 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.
  • Has knowledge of Design Control requirements.
  • 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.
  • ASQ Certifications a plus.
  • Experience in working in a regulated environment strongly preferred.
  • Cybersecurity, familiarity in AI, and cloud computing experience preferred.
  • 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.
  • Career development with an international company.
  • Recognized as a great place to work in dozens of countries.
  • Named one of the most admired companies in the world by Fortune.
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