Software Compliance Engineer

Abbott • Alameda, CA

1d • Onsite

About The Position

The Software Compliance Engineer 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. This person will monitor design controls that govern the development, verification, validation, use, and maintenance of medical device software. The Software Compliance Engineer will also coordinate activities with other engineering disciplines, departments, and contractors.

Requirements

• Bachelor’s degree, or equivalent experience, in a scientific, technical, or engineering discipline.
• 2 to 5 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 1 - 3 years project experience in software testing practices, methodologies including Agile and techniques, preferably in testing medical devices and mobile applications.

Nice To Haves

• Excellent oral and written communication skills.
• ASQ Certifications a plus.
• Medical Device experience strongly preferred.
• Cybersecurity, medical mobile applications or cloud computing experience preferred.

Responsibilities

• Reviews change plans for impact to project deliverables, and provides guidance to the document owners regarding changes to software requirements specifications, and software design descriptions for Abbott’s suite of diabetes management software (cloud and mobile).
• Reviews test plans and test reports to ensure all software changes are verified, and software system is adequately regressed across all environments in accordance with design controls and Quality System Requirements.
• Monitors defect management process and provides guidance to Systems Engineering and V&V teams to ensure software bugs are logged, investigated, tested and dispositioned.
• Active participant in an Agile software development process, including daily Scrum and other recurring Sprint ceremonies.
• 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.
• Assists in the development and maintenance of departmental operating procedures to ensure compliance to relevant FDA QSR, ISO guidelines (ISO 13485, ISO 14971), including 21 CFR Part 11 and Abbott Corporate requirements as they relate to the development, verification, validation, and maintenance of medical device software.
• Software Quality lead in various phases of the development lifecycle, as well as initiation of corrective and/or preventative action as it applies to software development activities.
• 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 SWQA compliance SME in support of external/internal audits.

Benefits

• 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 a 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees