Production Operator 2

Position Summary

To manufacture/test medical device assemblies (including all lower-level sub-assemblies and accessories) in a temperature-controlled clean room environment. To utilize a wide range of equipment, fixtures, gages and hand tools to manufacture assemble and test medical device products. To maintain all logs, forms and resulting paperwork. To carry out all facets of medical device assembly including organization of workflow and training of personnel at all levels.  

12 Hour shift. 5PM-5AM. Roating schedule- Weekday and weekend 

Principal Responsibilities

• Manufacture, inspect and package products following written processes  
• Work at a pace that meets established time standards while making quality product  
• Performs visual inspection of parts/materials to identify quality issues or workmanship deficiencies related to equipment, assembly and inspection processes, materials, sub-assemblies, and manufacturing environment  
• Comply with GMP requirements by maintaining individual training records, completing data entry in production records in a timely and accurate manner, and adhering to documented manufacturing practices and procedures as defined in Quality Systems Procedures  
• Maintain a clean, safe and organized work environment  
• Comply with all policies and procedures  
• Take ownership of assigned workstations and ensure consistent output quality by following established standards with minimal supervision 
• Support workflow by preparing materials, staging workstations, or troubleshooting minor equipment issues within scope 
• Provide informal guidance to less experienced operators when needed, modeling proper adherence to procedures and good manufacturing practices 
• Perform other duties as assigned  

Education / Experience Requirements

• High School Diploma or equivalent strongly preferred 
• Prior medical device manufacturing experience preferred. 
• Must be able to read and understand policies, procedures, and processes written in English. 
• Good hand-eye coordination, attention to detail, effective communication skills, and the ability to complete Assembler Quality System Training. 

Specialized Skills / Other Requirements

•    Ability to read and understand policies, procedures and processes written in English 
•    Good hand-eye coordination, attention to detail effective communication skills and ability to complete 
•    Assembler QS Training required