Shift -Sunday, Monday, Tuesday, and every other Wednesday 5:50am - 6:00pm This position requires high performance in the following areas: • Good Documentation Practices (GDP) • Maintain high product quality, minimize product complaints • Wear and maintain proper Personal Protective Equipment (PPE) • Must be able to discern color differences (No color blindness) • Must be able to detect defects in molded components by passing a Defect Awareness Test KEY RESPONSIBILITIES: • Complete daily tasks in accordance with Intertech Medical’s Policies and Procedures • Complete daily tasks in accordance with safety rules and regulations • Perform inspection of incoming raw materials and in process manufactured parts to current drawings, specifications, and work instructions • Record inspection data/results accurately • Support and follow ISO 13485 standards • Maintain work order history files and conduct final release of all history files • Identify and resolve issues with History files including GDP issues • Perform general 5S activities daily • Participate in and complete complaint investigations. • Create, monitor and complete non-conforming reports (NCRs) • Understand, apply and audit material and product traceability • Apply basic inspection concepts, techniques and processes • Apply risk assessment and mitigation using corrective and preventive action process including root cause analysis • Perform other duties and requests as assigned • Ability to interpret data including business metrics and technical information (example: Blueprints) • Understanding of Geometric Dimensioning and Tolerancing (GD T) • Assist engineering with creating and/or modifying tools, inspection programs, and fixtures. • Inspect and record of First Article Inspections (FAI) and daily inspections • Ability to work independently • Compile work orders • Create Certificates of Conformity (CofCs) • Assist in troubleshooting inspection equipment • Develop Quick Inspect content On-Site: This role is required to be on-site 5 days at the Denver, CO location.