If you’ve led quality in a high-volume manufacturing environment where compliance, production, and continuous improvement intersect, this is a role where your impact is immediately felt.
We’re partnered with a global medical technology manufacturer seeking a Quality Engineering leader to own site-level quality systems at a critical high-volume production facility in the Midwest.
This is a hands-on leadership role where quality directly drives production performance, product release, and customer confidence.
Role Impact
You’ll own the quality engineering function for a key manufacturing site, shaping execution, compliance, and continuous improvement:
- Lead site quality systems and QE support across high-volume manufacturing (molding, assembly, packaging, sterilization, release)
- Own validation strategy across processes, equipment, materials, and product changes
- Drive reduction in defects, complaints, and waste through effective corrective actions
- Lead audit readiness and regulatory inspection support
- Partner with Operations, Engineering, and Regulatory to improve performance and solve issues at the source
- Build and develop a small quality team
- Embed Lean/Six Sigma into daily operations and improvement efforts
- Support a 24/7 manufacturing environment
What You Bring
- Bachelor’s in Engineering or related field required
- 5+ years in quality, including 3+ in medical device or regulated manufacturing
- Strong validation, CAPA, and quality/statistical tools experience
- High-volume manufacturing background strongly preferred
- Proven leadership and cross-functional influence
- Must be a U.S. permanent resident or green card holder.
- Full benefits
Visa candidates are not being considered at this time
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