Job Description

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

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