Senior Specialist Quality Assurance

The Opportunity

The Senior Specialist Quality Assurance will participate 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.

You will review quality system documentation products as they apply to the development, verification, validation, use, and maintenance of medical device software.

In addition (but not limited to these activities), you will be asked to coordinate activities with other engineering disciplines, departments, and contractors.

What You'll Work On

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. Including direction of contract personnel to ensure projects come to fruition in a timely manner.

Reviews and provides lead guidance to the team regarding deliverables / activities as identified in the ADC Design Control Process / project plan or equivalent project plan.

Including System Specifications / Requirements documents, Verification Test Cases, Verification / Validation protocols, Trace Matrices and Verification / Validation Summary Reports for the Alameda site.

Reports unexpected events, issues or software bugs which occur during verification / validation to project team and management.

Assists subordinate staff in recognizing the same.

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 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.

Required Qualifications

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 and mobile applications.

Must have excellent oral and written communication skills.

Additional Qualifications

ASQ Certifications a plus.

Medical Device experience strongly preferred.

Cyber security, medical mobile applications or cloud computing experience preferred.