Software Quality Engineer

About the role

Participates as a member of the Software Quality Assurance (SWQA) team for Abbott Diabetes Care products that ensures digital applications produced by ADC is 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. Coordinate activities with other engineering disciplines, departments, and contractors.

Responsibilities

• Completes software quality tasks in accordance with current Quality System Requirements.
• Works independently with objectives given by SWQA Manager.
• Plans and coordinates 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.
• Safeguards unexpected events, issues or software bugs which occur during verification/validation by addressing and/or processing them under relevant design control and defect management procedures.
• Safeguards compliance to relevant FDA QSR, ISO guidelines (ISO 13485, ISO 14971), including 21 CFR Part 11 and Abbott Diabetes Care requirements as they relate to the development, verification, validation, and maintenance of medical device software.

Qualifications

• Bachelor’s degree, or equivalent experience, in a scientific, technical, or engineering discipline.
• 2 to 5 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 1 - 3 years project experience in software quality assurance practices, methodologies including Agile and techniques, preferably in medical device software such as web and mobile applications.
• Must have excellent oral and written communication skills.
• ASQ Certifications a plus.
• Medical Device experience strongly preferred.
• Cybersecurity, medical web and mobile applications or AI experience preferred.

Benefits

Upon Waiting Period Medical and Prescription Drug Plans
Dental Plan
Vision Plan
Health Savings Account (for High Deductible Health Plans)
Flexible Spending Accounts (Health, Limited Purpose, Dependent Care, Commuter Parking and Commuter Transit)
Supplemental Life Insurance
Short Term Disability (coverage varies by state)
Long Term Disability
Critical Illness, Hospital coverage, Accident Insurance
MetLife Legal, MetLife ID Fraud, and MetLife Pet Insurance
Abbott 401(k)