Senior Software Quality Assurance Engineer-Medical Device

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Job Title:

Senior Software Quality Assurance Engineer-Medical Device

Location:

Minneapolis, MN (onsite)

Duration:

Long-term Contract

Client:

Leading Medical Device Manufacturer

Senior Software Quality Assurance Engineer to support one of our strategic medical device clients in Minneapolis.

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 .

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