Senior Bioinformatics QA Engineer - NGS Cancer Diagnostics

Thornton Tomasetti; Northern (KY); Hybrid; USD 90,000 - 180,000; Full time

Benefits offered by this job

Health coverage

Tuition reimbursement

FreeU education benefit

High employer retirement contribution

Job summary

Abbott in La Jolla, CA seeks a Senior Bioinformatics Quality Engineer to ensure the quality of medical device software and bioinformatics pipelines supporting cancer diagnostics. You will develop verification plans, run software tests, and collaborate with scientists and IT to ensure compliance with IVD, IUO and LDT requirements.

The role emphasizes testing, documentation, and adherence to regulatory standards within an agile team focused on advancing next-generation sequencing applications.

Qualifications

• B.S. or higher in bioinformatics, computational biology, computer science, bioengineering, or related field.
• 5+ years of software quality/test engineering and/or bioinformatics experience.
• Familiarity with SDLC/Agile/Scrum environments.
• Proven ability to create verification/validation documentation (Verification Plans, Reports, Traceability).
• Experience with Git, CI/CD and regulated software development practices.

Responsibilities

• Develop and execute verification plans, protocols and test reports for software in medical devices and LDT/IVD products.
• Translate user and software requirements into executable verification and validation tests.
• Collaborate with bioinformatics scientists to define test inputs and strategy.
• Provide documentation support to Regulatory and Quality teams and ensure regulatory compliance.
• Mentor teammates in software quality processes and promote best practices.

Skills

Bioinformatics

Python

CI/CD

Software testing

Regulated SDLC

Education

B.S. Degree in Bioinformatics or related field

Tools

Git

Docker

Kubernetes

JAMA (Requirements Management)

Job description

Abbott in La Jolla, CA seeks a Senior Bioinformatics Quality Engineer to ensure the quality of medical device software and bioinformatics pipelines supporting cancer diagnostics. You will develop verification plans, run software tests, and collaborate with scientists and IT to ensure compliance with IVD, IUO and LDT requirements.

The role emphasizes testing, documentation, and adherence to regulatory standards within an agile team focused on advancing next-generation sequencing applications.