Medical Device Quality Inspector

Medical Device Quality Inspector 
Madison, WI 
Pay: $25.00 per hour 

Job Summary
The Medical Device Quality Inspector is responsible for ensuring that materials, processes, manufacturing activities, and finished medical device products meet current Good Manufacturing Practice (GMP) standards and comply with applicable regulatory and company quality system requirements. This role plays a critical part in maintaining product integrity by performing inspections, supporting documentation control, and assisting with quality investigations in a regulated medical device manufacturing environment.

Job Responsibilities

• Perform inspections of raw materials, in-process manufacturing products, and finished goods to ensure compliance with quality standards
• Review final documentation, labeling, and packaging for medical devices, subassemblies, and kits
• Complete and maintain accurate documentation of inspection activities and quality status labeling
• Support documentation control processes within the manufacturing environment
• Assist in investigations of nonconforming products and support preventive and corrective actions
• Conduct quality reviews for quarantine releases in accordance with established procedures
• Ensure proper storage, handling, and control of product and labeling materials
• Collaborate with manufacturing, engineering, and quality teams to resolve quality issues
• Maintain compliance with FDA Quality System Regulations and ISO 13485 standards
• Support continuous improvement of quality processes and systems

Job Requirements

• High school diploma or equivalent required
• Minimum of 1 year of experience in a regulated manufacturing or quality environment preferred
• Knowledge of FDA Quality System Regulations (QSR) and ISO 13485 standards preferred
• Strong attention to detail and ability to maintain accuracy in documentation
• Ability to work independently with a high level of motivation and accountability
• Strong communication skills, both written and verbal
• Ability to collaborate effectively across multiple departments
• Proficiency with computer-based systems and data entry

Education

• High school diploma or equivalent required

Work Experience

• At least 1 year of experience in a regulated environment preferred