• Handle complex tasks related to operating molding tools and equipment with minimal supervision
• Conduct quality inspections using gauges and fixtures, and monitor quality statistically to ensure compliance with standards
• Follow work instructions and Good Manufacturing Practice/Good Documentation Practice (GMP/GDP) requirements
• Handle materials and operate automated equipment
• Resolve issues as they arise
• Perform mold changes and collaborate with various departments
• Troubleshoot medical device molds
• Conduct optical tool inspection, assembly, set-up, targeting, line clearance, mechanical and negative checks, and changeover
• Operate the solvent supply and disposal system for production and research
• Adhere to Good Practice (GxP) regulations by strictly following Standard Operating Procedures (SOPs)
• Maintain accurate and complete documentation
• Ensure rigorous quality control and complete all required training
• Meet individual job requirements and contribute to the overall compliance of the organization
• Commit to continuous improvement and compliance with regulatory requirements.
• All associates must adhere to GxP regulations by strictly following Standard Operating Procedures (SOPs), maintaining accurate and complete documentation, ensuring rigorous quality control, and completing all required training.