Medical Device Quality Inspector – ISO 13485

TriMas Corporation; Denver (CO); On-site; USD 33,000 - 36,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Paid Time Off

Retirement Program

Job summary

Intertech Medical LLC in Denver, CO is seeking a Quality Inspector to join our on-site manufacturing team. You will perform incoming material and in-process part inspections against drawings and specifications, record data, and support ISO 13485 compliance.

The role requires attention to GDP, GD&T knowledge, ability to detect defects, and to work with tools and fixtures. You will contribute to non-conformity reports, CAPA activities, and maintain traceability across history files.

Qualifications

• 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

• Perform inspection of incoming raw materials and in-process parts to drawings, specs, 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.
• Create Certificates of Conformity (CofCs).
• Assist in troubleshooting inspection equipment.
• Inspect and record First Article Inspections (FAI) and daily inspections.

Skills

QA experience

Inspection skills

GDP awareness

GD&T understanding

Tools

Inspection tools

Job description

Intertech Medical LLC in Denver, CO is seeking a Quality Inspector to join our on-site manufacturing team. You will perform incoming material and in-process part inspections against drawings and specifications, record data, and support ISO 13485 compliance.

The role requires attention to GDP, GD&T knowledge, ability to detect defects, and to work with tools and fixtures. You will contribute to non-conformity reports, CAPA activities, and maintain traceability across history files.