Job Title: Quality Assurance Engineer

Duration: 12-Month Contract

Location: Milwaukee, WI 53214

Pay Rate: $30-$32/hr

Shift Time: 8:30 AM - 4:30 PM (Monday to Friday)

About the Role:

We're seeking a Quality Assurance Engineer to support our product lifecycle documentation and post-market quality data analysis. This role is essential in maintaining design control compliance, driving risk analysis, and supporting audit activities within an FDA-regulated environment.

What You'll Do:

Ensure accurate compilation and maintenance of product Design History Files (DHF)
Perform independent DHF audits and archive device/design records in electronic searchable format
Analyze post-market quality data (complaints and service records) for failure trends
Document traceability from design inputs to verification and validation outputs
Apply robust statistical techniques during product development and design changes
Support external audits (regulatory/customer) and perform related quality duties as required

What We're Looking For:

2+ years of relevant work experience
Solid understanding of FDA 21 CFR 820.30 and ISO 13485 design control requirements
Familiarity with ISO 14971 and risk management standards
Experience with statistical tools for data analysis
Ability to read and interpret technical documentation (schematics, diagrams, flowcharts)
Proficient in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook)
ASQ certification or similar is a plus
Prior experience in an FDA-regulated environment preferred

Integration International Inc.

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Quality Assurance Engineer