Quality Assurance Lab Technician II (3rd Shift)

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.