Quality Manager

Design Hire•Racine, WI
•Onsite

About The Position

Design Hire is seeking a Quality Manager to lead quality systems, inspection activity, and compliance efforts within a regulated manufacturing environment. This role is a strong fit for someone with hands-on quality leadership experience who can improve processes, support audits, and maintain high standards across production and documentation.

Requirements

  • 5+ years of quality experience in a manufacturing environment preferred.
  • Prior quality leadership or management experience required.
  • Medical device manufacturing experience strongly preferred.
  • Working knowledge of FDA audit requirements and regulated quality systems.
  • Experience with ISO 13485 preferred.
  • Background supporting fabrication processes, inspection methods, and production quality controls.
  • Strong understanding of corrective actions, root cause analysis, nonconformance handling, and documentation practices.
  • Strong communication, organization, accountability, and cross-functional leadership skills.

Responsibilities

  • Manage quality management activities across inspection, documentation, corrective actions, and process controls.
  • Lead internal audit readiness and support external regulatory or customer audits.
  • Oversee quality inspection processes to ensure products meet specifications, standards, and release requirements.
  • Partner with operations, engineering, and production teams to resolve quality issues and improve manufacturing performance.
  • Maintain and improve procedures, records, training, and quality system documentation.
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