Quality Engineering Manager

Hobson Associates; Nebraska; On-site; USD 110,000 - 170,000; Full time

Benefits offered by this job

Full benefits

Job summary

Hobson Associates in the Midwest seeks a Quality Engineering leader to own site-level quality systems at a high-volume medical device production site. This is a hands-on, leadership role where quality directly drives production performance, product release, and customer confidence.

You will lead the quality engineering function, shaping compliance, validation, CAPA, and continuous improvement with cross-functional partners in Operations, Engineering, and Regulatory.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Quality leadership

Validation

CAPA

Statistical tools

Lean Six Sigma

Cross-functional influence

Education

Bachelor’s in Engineering or related field

Job description

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