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 107,000 colleagues serve people in more than 160 countries
At Abbott, we believe people with diabetes should have the freedom to enjoy active lives. That's why we're focused on helping people with diabetes manage their health more effectively and comfortably, 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.
We have an opportunity for a Software Quality Engineer at our Alameda, CA location.
You will ensure that software quality assurance computerized systems used in the support of the Quality System are developed, validated and maintained in compliance with regulatory and corporate requirements. Participates as a member of the project team for ADC products that incorporate software/firmware into their system. Review quality system documentation products as they apply to the development, verification, validation, use, and maintenance of the software or firmware. Coordinate activities with other engineering disciplines, departments and contractors. Estimate, plan and review own and others' work
WHAT YOU'LL DO
- Completes SWQA 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 pre-defined deliverables/activities as identified in the SWQA Non-Product Quality Process and/or SWQA Product Quality Process/project plan or equivalent project plan.
- Provide accuracy, clarity, consistency, completeness and compliance for multiple projects. Including System Specifications/Requirements documents, Verification Test Cases, Verification/Validation protocols, Trace Matrices and Verification/Validation Summary Reports for the Alameda site.
- Report unexpected events, issues or software bugs which occur during verification/validation to project team and management.
- Develops and maintains 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 computerized systems used in the Quality System as well as those used in development of ADC software/firmware products.
- May develop and maintain Validation Master Plan(s).
EDUCATION AND EXPERIENCE YOU WILL BRING
- Bachelor's degree, or equivalent experience, in a scientific, technical, or engineering discipline.
- 5 to 8 years experience in Software Quality Assurance. Knowledge of FDA QSR, ISO guidelines and 21 CFR Part 11.
- In particular, has knowledge of Design Control requirements.
- Must have 2 - 4 years project experience in software testing practices, methodologies and techniques, preference in testing medical devices.
- Experience leading test engineer team is a plus. Must have excellent oral and written communication skills. Knowledge of DOORs application is a plus. ASQ Certifications a plus.
- Experience in Mobile app testing and Cybersecurity highly desired.
WHAT WE OFFER
At Abbott, you can have a good job that can grow into a great career. We offer:
- A fast-paced work environment where your contribution is essential to success
- Training and career development, with onboarding programs for new employees and tuition assistance
- Financial security through competitive compensation, incentives and retirement plans
- Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
- Paid time off
- 401(k) retirement savings with a generous company match
- The stability of a company with a record of strong financial performance and history of being actively involved in local communities
Learn more about our benefits that add real value to your life to help you l