Manager, Quality Engineering

Quality Engineering Leader

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
• Lean/Six Sigma exposure a plus Proven leadership and cross-functional influence
• Must be a U.S. permanent resident or authorized to work in the U.S.

Compensation & Benefits

• Competitive base salary
• Full benefits
• Relocation support available