Quality Inspector
$45,760–$54,208 year
On-site · Longmont, Colorado, United States
Job Summary
Quality Control Inspector ensuring Class II and Class III medical devices meet quality standards and regulatory requirements throughout manufacturing. Conduct visual and functional inspections across production stages using precision measuring equipment (calipers, micrometers, measuring microscope, height gauge) and document defects/non-conformities. Follow established inspection procedures, perform final checks before shipment, maintain detailed inspection records, and assist with root cause analysis and corrective actions. Collaborate with manufacturing, engineering, and QA teams; assist in training personnel on quality procedures. Requires a high attention to detail, ability to read engineering drawings, knowledge of FDA and ISO 13485:2016 standards, and prior experience in medical device or pharmaceutical manufacturing.
Required Qualifications
- High school diploma/GED preferred
- Minimum of 2 years of experience as a quality inspector, medical device or pharmaceutical manufacturing environment
- Strong understanding of FDA regulations and ISO standards for medical devices (ISO 13485:2016)
- Proficiency with precision measuring equipment and tools (calipers, micrometers, measuring microscope, gauges)
- Proficiency in reading engineering drawings
- Excellent attention to detail and ability to identify defects and non-conformities
- Knowledge of statistical process control and quality control methodologies
- Strong communication and interpersonal skills
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