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
FAQs
Congratulations, we understand that taking the time to apply is a big step. When you apply, your details go directly to the consultant who is sourcing talent. Due to demand, we may not get back to all applicants that have applied. However, we always keep your CV and details on file so when we see similar roles or see skillsets that drive growth in organisations, we will always reach out to discuss opportunities.
Yes. Even if this role isn’t a perfect match, applying allows us to understand your expertise and ambitions, ensuring you're on our radar for the right opportunity when it arises.
We also work in several ways, firstly we advertise our roles available on our site, however, often due to confidentiality we may not post all. We also work with clients who are more focused on skills and understanding what is required to future-proof their business.
That's why we recommend registering your CV so you can be considered for roles that have yet to be created.
Yes, we help with CV and interview preparation. From customised support on how to optimise your CV to interview preparation and compensation negotiations, we advocate for you throughout your next career move.