Quality Manager

Design Hire LLC • Racine, WI

82d • $85,000 - $100,000

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

• Prior quality leadership or management experience required.
• Working knowledge of FDA audit requirements and regulated quality systems.
• 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.

Nice To Haves

• 5+ years of quality experience in a manufacturing environment preferred.
• Medical device manufacturing experience strongly preferred.
• Experience with ISO 13485 preferred.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Education Level: No Education Listed