Quality Inspector — ISO 13485 (Injection Molding) On-site

Intertech Medical LLC; Denver (CO); On-site; USD 3,258,000 - 3,582,000; Full time

Job summary

Intertech Medical LLC is seeking a Quality Inspector for an on-site full-time hourly position in Denver, CO. You will inspect incoming materials and in-process parts, ensure GDP compliance, record data, and support ISO 13485 standards.

Responsibilities include 5S activities, NCR handling, traceability, and collaborating with engineering on tools and fixtures. A color-vision requirement and attention to quality are essential.

Qualifications

• GDP knowledge and ISO 13485 compliance.
• Able to discern color differences.
• Detect defects in molded components (DefectAwareness).
• Maintain accurate inspection documentation.
• Basic math and use of inspection tools.
• Familiarity with 5S and GMP principles.

Responsibilities

• Complete daily tasks per Intertech Policies and Procedures.
• Follow safety rules and regulations.
• Inspect incoming raw materials and in-process parts to drawings/specs.
• Record inspection data/results accurately.
• Support ISO 13485 standards.
• Maintain work order history files and final release of history files.
• Identify and resolve issues with history files including GDP issues.
• Perform 5S daily.
• Participate in complaint investigations.
• Create, monitor and complete NCRs.
• Understand, apply and audit material and product traceability.
• Apply basic inspection concepts and processes.
• Apply risk assessment and CAPA/root cause analysis.
• Perform other duties as assigned.
• Interpret data including metrics and technical information (e.g., blueprints).
• Understand GD&T.
• Assist engineering with tools, inspection programs, and fixtures.
• Inspect and record First Article Inspections (FAI) and daily inspections.
• Work independently.
• Compile work orders.
• Create Certificates of Conformity (CoCs).
• Assist in troubleshooting inspection equipment.
• Develop Quick Inspect content.

Skills

GDP

Color vision

Defect detection

PPE use

5S

Data interpretation

GD&T understanding

Quality standards

Job description

Intertech Medical LLC is seeking a Quality Inspector for an on-site full-time hourly position in Denver, CO. You will inspect incoming materials and in-process parts, ensure GDP compliance, record data, and support ISO 13485 standards.

Responsibilities include 5S activities, NCR handling, traceability, and collaborating with engineering on tools and fixtures. A color-vision requirement and attention to quality are essential.