Quality Assurance Lab Technician II (3rd Shift)

Chemline, Inc.; Northern (KY); Hybrid; USD 45,000 - 65,000; Full time

Job summary

Chemline, Inc. in Northern Kentucky is seeking a detail-oriented Quality Assurance Lab Technician to ensure our manufacturing processes meet rigorous quality standards.

You will perform precise measurements, inspections, and data analysis to support compliance with ISO 13485, ISO 9001, GMP, and FDA regulations. You will operate height gauges, CMMs, and vision systems, interpret blueprints and GD&T, conduct material and product inspections, maintain calibration schedules, and participate in

Qualifications

• Proven experience in quality assurance in a manufacturing environment.
• Familiarity with ISO 13485 and ISO 9001, GMP, FDA regulations.
• Ability to read mechanical drawings and GD&T.
• Experience with quality audits and data analysis.

Responsibilities

• Conduct dimensional measurements using precision instruments (height gauges, CMM, vision systems).
• Perform quality inspections on materials, components, and finished products to ISO/GMP/FDA standards.
• Interpret blueprints, drawings, and GD&T to assess conformity.
• Execute internal quality audits and support QMS reviews.
• Collect and analyze quality data to support continuous improvement.
• Maintain calibration schedules for measuring equipment and regulatory compliance.
• Assist with root cause analysis of defects and non-conformances.

Skills

Attention to detail

Analytical skills

Strong communication

Math/calculation proficiency

Tools

Height gauges

Coordinate Measuring Machines (CMM)

Vision inspection systems

Job description

Description

Schedule: First Shift, Monday–Friday, 9:00 a.m.–5:30 a.m.

We are seeking a detail-oriented and energetic Quality Assurance Lab Technician to join our dynamic team. In this vital role, you will ensure that our manufacturing processes meet rigorous quality standards by performing precise measurements, inspections, and analysis. Your expertise will help maintain compliance with industry regulations and uphold our reputation for excellence in product quality.

• Conduct dimensional measurements using precision instruments such as height gauges, coordinate measuring machines (CMM), and vision inspection systems to verify product specifications.
• Perform quality inspections on raw materials, in-process components, and finished products to ensure adherence to ISO 13485, ISO 9001, GMP (Good Manufacturing Practice), and FDA regulations.
• Interpret manufacturing and production documents, blueprints, and mechanical drawings to accurately assess product conformity.
• Execute quality audits and participate in internal quality management system reviews to identify areas for improvement.
• Collect and analyze data related to product quality, measurement results, and inspection outcomes to support continuous improvement initiatives.
• Maintain calibration schedules for measuring instruments and ensure all equipment complies with regulatory standards such as HACCP and CGMP.
• Support manufacturing teams by providing guidance on quality standards in production and assisting with root cause analysis of defects or non-conformances.

Requirements

• Proven experience in quality assurance or quality control within a manufacturing environment, preferably involving medical devices or similar regulated industries.
• Strong knowledge of ISO standards (ISO 13485, ISO 9001), GMP practices, FDA regulations, and regulatory/legal compliance standards.
• Proficiency with measurement instruments including height gauges, coordinate measuring machines (CMM), vision inspection systems, and other precision measurement tools.
• Mechanical knowledge coupled with the ability to interpret mechanical blueprints and GD&T (Geometric Dimensioning & Tolerancing).
• Familiarity with quality systems such as QA/QC processes, data collection techniques, and conducting quality audits.
• Excellent analysis skills with attention to detail; ability to perform accurate dimensional measurements and interpret manufacturing documentation.
• Basic math skills necessary for precise measurement calculations and data analysis.
• Strong communication skills to collaborate effectively across teams and document inspection results clearly.