Job Description

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. 

Our location in Alameda, CA, currently has an opportunity for a SWQA COMPLIANCE ENGINEER III. This person will Ensure that SWQA 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 products.

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.
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 the development of ADC software/firmware products.
Ensures that appropriate procedures, controls, and disaster recovery plans are incorporated into new computerized systems.
May Develop and maintain Validation Master Plan(s).
This is an individual contributor position which may have responsibilities to monitor and direct the work of contractors/temporaries.
Ensures that ADC computerized systems used in the support of the Quality System are developed, validated and maintained in compliance with regulatory and corporate requirements.
Ensures that deliverables and activities are in compliance with current Software/SWQA processes in the development of ADC software/firmware products.

EDUCATION AND EXPERIENCE YOU’LL BRING

REQUIRED

Bachelors degree, or equivalent experience, in a scientific, technical, or engineering discipline. 
5 to 8 years experience in Software Quality Assurance.
Knowledge of FDA QSR, relevant 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, preferably in testing medical devices.
Experience leading test engineer team is a plus. Must have excellent oral and written communication skills. 

PREFERRED QUALIFICATIONS

 Knowledge of DOORs application is a plus. 
ASQ Certifications a plus.

WHAT WE OFFER

At Abbott, you can have a good job that can grow into a great career. We offer:

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