Operations Associate - Medical Device

Position Summary
We are seeking a Contract to Hire Cleanroom Operations Associate. The Cleanroom Operations Associate supports manufacturing operations in a regulated medical device environment. This role ensures product integrity, traceability, accurate documentation, and regulatory compliance while operating equipment, assembling products, and maintaining cleanroom standards.

Responsibilities

• Perform routine cleaning, maintenance, and monitoring of cleanroom and controlled areas
• Operate automated machinery, measurement tools, label printers, and related equipment
• Assemble and package medical devices
• Assist with shutdowns and operational events
• Support engineering with troubleshooting and process improvements
• Maintain product integrity and traceability through accurate documentation of Manufacturing Orders
• Complete and maintain regulatory batch records
• Follow Quality Management System (QMS) requirements
• Maintain a safe work environment in a regulated setting
• Assist with cleanroom inventory control

Requirements

• Detail-oriented and able to follow structured procedures and work instructions
• Able to work independently with minimal supervision
• Proficient in Microsoft Office (Excel required)
• Comfortable working in a cleanroom environment with required garments and PPE
• High School Diploma or equivalent
• 2+ years in production or manufacturing environment preferred
• Medical device manufacturing experience preferred
• Cleanroom experience preferred