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