Quality Inspector

TriMas Corporation•Denver, CO

13d•Onsite

About The Position

This position requires high performance in the following areas: Good Documentation Practices (GDP), maintaining high product quality, minimizing product complaints, wearing and maintaining proper Personal Protective Equipment (PPE), discerning color differences (no color blindness), and detecting defects in molded components by passing a Defect Awareness Test. The role involves completing daily tasks in accordance with Intertech Medical’s Policies and Procedures, safety rules and regulations, performing inspections of incoming raw materials and in-process manufactured parts, recording inspection data accurately, supporting and following ISO 13485 standards, maintaining work order history files, conducting final release of all history files, identifying and resolving issues with History files including GDP issues, performing general 5S activities daily, participating in and completing complaint investigations, creating, monitoring, and completing non-conforming reports (NCRs), understanding, applying, and auditing material and product traceability, applying basic inspection concepts, techniques, and processes, applying risk assessment and mitigation using corrective and preventive action processes including root cause analysis, and performing other duties and requests as assigned. The role also requires the ability to interpret data including business metrics and technical information (e.g., Blueprints), understanding of Geometric Dimensioning and Tolerancing (GD&T), assisting engineering with creating and/or modifying tools, inspection programs, and fixtures, inspecting and recording of First Article Inspections (FAI) and daily inspections, the ability to work independently, compiling work orders, creating Certificates of Conformity (CofCs), assisting in troubleshooting inspection equipment, and developing Quick Inspect content.

Requirements

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
Ability to interpret data including business metrics and technical information (example: Blueprints)
Understanding of Geometric Dimensioning and Tolerancing (GD&T)
Ability to work independently
Previous injection molding, manufacturing, QA experience preferred
Previous experience in an ISO 13485 regulated environment preferred
Knowledge of and use of relevant computer software applications and skills to use them effectively
Basic math skills
Knowledge and use of various inspection tool, methods, and techniques

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
Inspect and record of First Article Inspections (FAI) and daily inspections
Compile work orders
Create Certificates of Conformity (CofCs)
Assist in troubleshooting inspection equipment
Develop Quick Inspect content