Software Quality Engineer III

Software Quality Assurance Engineer - Medical Device (Hybrid, Minneapolis)

A leading medical device company is seeking a skilled Software Quality Assurance Engineer to support critical systems across its Maple Grove facility. This role is ideal for someone with a strong background in software QA within an ISO 13485 environment, who thrives in high-stakes, compliance-driven settings.

Responsibilities include:

* Reviewing test documentation, change controls, and validation artifacts for systems used in manufacturing and laboratory environments
* Acting as the final sign-off authority, ensuring all documentation is accurate, error-free, and compliant with FDA and third-party regulatory standards
* Supporting systems across multiple divisions, including IC, Cardiology, and PI
* Working with a variety of equipment such as lasers, welders, bonders, ovens, incubators, and other lab/manufacturing tools
* Maintaining strict compliance and documentation accuracy to avoid regulatory risks

Qualifications:

* Experience in software quality assurance within a regulated environment (ISO 13485 preferred)
* Familiarity with computer system validation (CSV) and verification & validation (V&V) processes
* Strong attention to detail and a commitment to documentation excellence
* Ability to work cross-functionally and support multiple systems and departments

This is a hybrid role based in Minneapolis. If you're interested in learning more or applying, please reach out with your CV and contact adam.tizabi@epmscientific.com