Quality Manager - Medical Device & Audit Readiness

Design Hire LLC; Racine (WI); On-site; USD 90,000 - 130,000; Full time

Job summary

Design Hire LLC in Racine, Wisconsin, is seeking a Quality Manager to lead quality systems, inspection activity, and compliance within a regulated manufacturing environment. The role focuses on improving processes, supporting audits, and maintaining high standards across production and documentation.

The new manager will drive internal audits, support external regulatory or customer audits, and ensure product conformance by overseeing inspection processes and quality records in collaboration

Qualifications

• 5+ years of quality leadership in a manufacturing environment.
• Experience supporting medical device quality systems and documentation.
• Strong knowledge of regulatory requirements (FDA) and ISO 13485.

Responsibilities

• Manage quality 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 and release requirements.
• Partner with operations, engineering, and production teams to resolve quality issues and improve performance.
• Maintain and improve procedures, records, training, and quality system documentation.

Skills

Quality leadership

FDA audits

ISO 13485

Root cause analysis

Cross-functional leadership

Job description

Design Hire LLC in Racine, Wisconsin, is seeking a Quality Manager to lead quality systems, inspection activity, and compliance within a regulated manufacturing environment. The role focuses on improving processes, supporting audits, and maintaining high standards across production and documentation.

The new manager will drive internal audits, support external regulatory or customer audits, and ensure product conformance by overseeing inspection processes and quality records in collaboration