• Manage highly complex tasks related to operating molding tools and equipment and/or manufacturing machine tools and fixtures with minimal supervision
• Perform detailed 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 complex issues as they arise
• Lead 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, changeover, and operate the solvent supply and disposal system for production and research
• Adhere to Good Practice (GxP) regulations by strictly following Standard Operating Procedures (SOPs), maintaining accurate and complete documentation, ensuring rigorous quality control, and completing 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. Associates are responsible for meeting their individual job requirements and contributing to the overall compliance of the organization. Compliance with regulatory requirements and a commitment to continuous improvement are essential to our operations.