Senior Software Quality Engineer – Design Controls

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 160 countries.

JOB DESCRIPTION:

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. 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 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.

A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.

A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity This position works out of our Alameda, CA location in the Diabetes Care division where we are focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology.

The Senior Software Quality Engineer – Design Controls will be responsible for (but not limited to) the following:

Participates as a lead member of the Software Quality Assurance (SWQA) team for Abbott Diabetes Care products to ensure medical device software is developed, tested and deployed in adherence to design control procedures.

Engages cross-functionally with R&D teams (systems engineering, project management, software development and test) to review and approve DHF deliverables.

Supports Agile teams as embedded design control SME throughout the product development and release cycle.

Drives compliance to defect management process to ensure investigations are timely and thorough, risks/hazards are assessed, and fixes are implemented.

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.

Reviews and provides lead guidance to the team regarding deliverables/activities as identified in project plans or equivalent documentation. 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.

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 as they relate to the development, verification, validation, and maintenance of application in support 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.

2 to 5 years’ experience in Software Design Quality Assurance and/or Software Testing experience.

Knowledge of FDA QSR, relevant ISO guidelines and 21 CFR Part 11. Has knowledge of Design Control and Risk Management 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.

Preferred Qualifications

Must have excellent oral and written communication skills.

ASQ Certifications a plus.

Medical Device experience strongly preferred.

Cybersecurity, medical mobile applications or cloud computing experience preferred.

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: https://abbottbenefits.com/

Connect with us at abbott.com, on LinkedIn at https://www.linkedin.com/company/abbott-/, and on Facebook at https://www.facebook.com/AbbottCareers.

The base pay for this position is $90,000.00 – $180,000.00 In specific locations, the pay range may vary from the range posted.

JOB FAMILY: Operations Quality

DIVISION: ADC Diabetes Care

LOCATION: United States > Alameda : 2901 Harbor Bay Parkway

ADDITIONAL LOCATIONS: United States > Milpitas : 1820 McCarthy Blvd

WORK SHIFT: Standard

TRAVEL: Yes, 10 % of the Time

MEDICAL SURVEILLANCE: No

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)