Software Quality Engineer

Abbott; Alameda (CA); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Medical Plan

Dental Plan

Vision Plan

Health Savings Account

Flexible Spending Accounts

Life Insurance

Short Term Disability

Long Term Disability

401(k)

Job summary

Abbott in Alameda, CA is seeking a Software Quality Engineer for a 12‑month, onsite assignment to support ADC medical device software development, validation, and maintenance in compliance with FDA QSR, ISO 13485, and 21 CFR Part 11.

You will review design control documents, verification protocols, and test reports; coordinate with engineering disciplines; and ensure quality system requirements are met. Strong communication and Agile experience are preferred.

Qualifications

• Bachelor’s degree in a scientific, technical, or engineering field or equivalent experience.
• 2–5 years of Software Quality Assurance and/or Software Testing experience.
• Knowledge of FDA QSR, ISO guidelines, and 21 CFR Part 11; design control requirements.
• 1–3 years project experience in software quality assurance practices and agile methodologies, preferably in medical device software.
• Excellent oral and written communication skills.
• ASQ certifications are a plus.
• Medical device experience strongly preferred; cybersecurity, medical web and mobile apps or AI experience preferred.

Responsibilities

• Completes software quality tasks in accordance with current Quality System Requirements.
• Works independently with objectives from SWQA Manager and coordinates with higher-level schedules.
• Reviews deliverables per ADC Design Control Process: specs, test cases, protocols, trace matrices, V&V reports.
• Ensures issues from verification/validation are addressed under design control and defect procedures.
• Ensures compliance to FDA QSR, ISO guidelines, and 21 CFR Part 11 in medical device software development and maintenance.

Skills

Communication skills

Agile

Regulatory knowledge

Education

Bachelor’s degree

Job description

100% Onsite

Title: Software Quality Engineer

Location: Alameda, CA

Duration: 12 Month Assignment

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

Duties

• 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 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.
• Ensures unexpected events, issues or software bugs which occur during verification/validation are addressed and/or processed under relevant design control and defect management procedures.
• Ensures 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.

Consultants Eligible 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
• 401(k)