Sr. Specialist Quality Assurance

Abbott • Alameda, CA

16h • $90,000 - $180,000

About The Position

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: Sr. Specialist Quality Assurance Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and 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. 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 - an affordable and convenient path to getting a bachelor’s degree. A company recognized as a great place to work in dozens of countries around the world 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 a best place to work for diversity, working mothers, female executives, and scientists. The Opportunity Participates as a member of the Non-Product Software Quality Assurance (SWQA) team for Abbott Diabetes Care. Ensures systems / applications produced in support of the Quality System or consumer products are 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 or systems /applications in support of the Quality System. 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 Management. Can plan and coordinate own work according to higher-level project schedules. Reviews 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. Ensures 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. Supports ADC Non-Product Software Lifecycle process improvement initiatives.

Requirements

• Bachelor’s degree, or equivalent experience, in a scientific, technical, or engineering discipline.
• Min 5 years’ experience in Software Quality Assurance and Software Testing experience.
• Knowledge of FDA QSR, relevant ISO guidelines and 21 CFR Part 11.
• Has knowledge of Design Control requirements.
• Must have 2-5 years project experience across the software lifecycle, including methodologies such as Agile and associated techniques; experience with medical devices and mobile applications is preferred.
• Must have excellent oral and written communication skills.

Nice To Haves

• Medical Device and AI experience are strongly preferred.
• Cybersecurity or cloud computing experience preferred.
• ASQ Certifications a plus.

Responsibilities

• Completes software quality tasks in accordance with current Quality System Requirements.
• Works independently with objectives given by SWQA Management.
• Can plan and coordinate own work according to higher-level project schedules.
• Reviews 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.
• Ensures 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.
• Supports ADC Non-Product Software Lifecycle process improvement initiatives.

Benefits

• Career development with an international company where you can grow the career you dream of.
• 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 - an affordable and convenient path to getting a bachelor’s degree.
• A company recognized as a great place to work in dozens of countries around the world 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 a best place to work for diversity, working mothers, female executives, and scientists.

What This Job Offers

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