Onsite Software Quality Engineer – Medical Devices

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

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.