Senior Software Quality Assurance Engineer-Medical Device

Senior Software Quality Assurance Engineer-Medical Device

We have an exciting open position for a

Senior Software Quality Assurance Engineer

to support one of our strategic medical device clients in Minneapolis. Job Details: Job Title:

Senior Software Quality Assurance Engineer-Medical Device Location:

Minneapolis, MN - onsite Duration:

Long-term Contract Client:

Leading Medical Device Manufacturer Required Qualifications: 6–10 years

of experience in software quality within medical devices or similarly regulated environments. Expert knowledge of

IEC 62304 ,

ISO 13485 ,

ISO 14971 , and

FDA QSR (21 CFR Part 820) . Experience supporting

regulatory submissions , especially for Class II/III devices. Proficiency in

automated testing frameworks

(e.g., Selenium, Appium) and

scripting languages

such as Python or Java. Strong working knowledge of tools like

Jira ,

TestRail ,

Azure DevOps , or equivalent. Proven leadership in multi-project quality oversight and regulatory inspection preparation. Preferred Qualifications: Experience with

Software as a Medical Device (SaMD)

and

connected health ecosystems . Understanding of

cybersecurity frameworks ,

HIPAA compliance , and

data integrity controls . ASQ certifications (e.g.,

CQA ,

CQE ) or formal training in quality auditing. Excellent verbal and written communication skills, with the ability to lead across

matrixed cross-functional teams . We are an equal opportunities employer and welcome applications from all qualified candidates.

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