Quality Inspector – Medical Devices (ISO 13485)

Injectech LLC; Fort Collins (CO); On-site; USD 42,000 - 62,000; Full time

Benefits offered by this job

401(K) Retirement Plan

Profit Share Program

Medical, Dental, Vision, Life & AD&D

Job summary

Injectech, LLC is seeking a Quality Inspector to ensure product conformity and compliance with ISO 13485 and GDP standards. The role focuses on incoming material inspection, process testing, and data recording in a Fort Collins, CO environment.

The ideal candidate has a high school diploma, basic math skills, experience with inspection tools, and strong attention to detail. This is an on-site position with participation in internal audits and continuous improvement initiatives.

Qualifications

• High school diploma or equivalent is required; technical training or certification is preferred.
• Experience in quality inspection or regulated manufacturing environments is preferred.
• Cleanroom familiarity and willingness to complete gowning/training are required.
• Solid understanding of GDP, GDP controlled documentation, and ISO 13485 principles.

Responsibilities

• Inspect incoming materials, in-process components, and finished products per established specs and work instructions.
• Collect, record, and analyze inspection data with GDP; ensure documentation accuracy.
• Review product and process docs to verify conformance with requirements.
• Identify nonconforming materials and communicate disposition per procedures.
• Support investigations into quality issues and corrective actions.
• Maintain quality records per QMS and company procedures.

Skills

Attention to detail

Reading drawings

English communication

Teamwork

Multitasking

Education

High school diploma or equivalent

Technical training preferred

Tools

GDP documentation practices

ISO 13485 knowledge

eQMS familiarity

Calibrated measuring equipment

Job description

Injectech, LLC is seeking a Quality Inspector to ensure product conformity and compliance with ISO 13485 and GDP standards. The role focuses on incoming material inspection, process testing, and data recording in a Fort Collins, CO environment.

The ideal candidate has a high school diploma, basic math skills, experience with inspection tools, and strong attention to detail. This is an on-site position with participation in internal audits and continuous improvement initiatives.