Quality Inspector

Job Title: Quality Inspector Medical Device Manufacturing

Location: Madison, WI

Job Type: Contract or Full-Time (as applicable)



Job Description:



We are seeking a Quality Inspector to support daily device manufacturing operations in a medical device environment. This role ensures all processes, materials, and documentation comply with current Good Manufacturing Practices (cGMP), internal quality systems, and regulatory standards, including FDA QSR and ISO 13485.



Key Responsibilities:

• Perform inspections in one or more of the following areas:
  • Incoming raw materials
  • In-process manufacturing activities
  • Final device packaging and documentation
• Ensure documentation accuracy and proper labeling of materials.
• Assist with document control and support quality record retention in the manufacturing site.
• Conduct quality reviews on quarantined materials and assist in non-conformance investigations.
• Maintain product handling and labeling in a controlled and secure manner.
• Collaborate with manufacturing, engineering, and QA to support quality issue resolution and process improvements.

Minimum Requirements:

• High school diploma or equivalent (Associate's preferred).
• 1+ year experience in a regulated environment (medical device, pharma, or biotech preferred).
• Familiarity with FDA Quality System Regulations and ISO 13485.
• Strong attention to detail and documentation accuracy.
• Comfortable working with computer-based systems and electronic records.

Preferred Competencies:

• Motivated, self-driven, and able to work with minimal supervision.
• Excellent communication skills verbal and written.
• Strong teamwork and collaboration abilities.
• Prior experience in quality, document control, or inspection roles in a GMP environment.

Work Environment:

• Controlled manufacturing environment for medical devices and accessories.
• Requires mobility within the facility and interaction across production, quality, and engineering functions.