Medical Device Quality Inspector - Madison, WI

About the role

Responsible for assuring that materials, activities, processes, and specified conditions related to the daily device manufacturing, processing and packaging meet current GMP standards and comply with applicable procedures and standards.

Responsibilities

• Inspecting raw materials to meet production requirements
• Conducts in-process inspection of manufacturing product and processes
• Reviews final documentation and shipment packaging for medical devices, subassemblies, and kits
• Assists in the Madison Manufacturing documentation control room
• Completes documentation of activities performed, prepares and attaches material quality status labeling
• Ensures storage and handling of product and labeling in a controlled and secure manner
• Supports Quality through occasional conduct of investigations of nonconformance, assists with preventive actions associated with the QA unit
• Performs quality reviews for quarantine releases on non-reportable, non-compliant, RMF-3 internal to an RSC

Requirements

• High School diploma or equivalent
• One year’s experience in a regulated work environment preferred
• Knowledge of FDA Quality System Regulations and ISO13485 pertaining to medical device manufacturing

Skills

• High Level of motivation; ability to work independently
• Detailed oriented
• Ability to work with computer-based systems daily
• Collaborator with strong levels of engagement with individuals and as a team member
• Good interpersonal skills; ability to communicate well, both verbally and written