Job Title: Quality Inspector

We are seeking a diligent Quality Inspector to join our team. The ideal candidate will be responsible for ensuring products meet quality standards by inspecting and documenting various quality issues according to ISO and FDA requirements. This role involves using precision measuring instruments and working within a medical device manufacturing environment.

• Interpret specifications and blueprints to understand dimensional, physical, functional, and visual requirements.
• Inspect products for quality issues and document findings in the ERP system per ISO and FDA standards.
• Perform part inspection and measure dimensions of incoming, in-process, first piece, and finished workpieces.
• Utilize precision measuring instruments, optical comparators, CMM or vision machines, along with templates and fixtures.
• Assist with Corrective and Preventive Actions (CAPA), Non-Conformance Reports (NCR), and other non-conformance issues.
• Collect data and enter it into spreadsheets and databases.
• Support dispositions of nonconforming products, including internal issues or customer returns through the RMA procedure.

• Inspection experience
• Knowledge of Quality standards
• Experience with ISO 13485
• Proficiency in CAPA and NCR processes
• Ability to use micrometers and calipers
• Minimum of 3 years of quality experience

• Experience in a medical device manufacturing environment is beneficial

The position operates within a medical device manufacturer and office setting. Initial training will occur on the 1st shift (6:00am – 2:30pm, Mon-Fri) before transitioning to the 2nd shift (2:30pm – 1:00am). Potential for overtime exists depending on workflow, with an expected increase in business potentially requiring additional hours per week.

This is a Contract to Hire position based out of Kenosha, Wisconsin.