Quality Assurance Lab Technician II (1st Shift)

Chemline, Inc.; St. Louis (MO); On-site; USD 54,000 - 74,000; Full time

Job summary

Chemline, Inc. is seeking a detail-oriented Quality Assurance Lab Technician to join our team in St. Louis.

You will perform precise measurements, inspections, and analyses to ensure our medical device manufacturing meets stringent quality standards. Responsibilities include using height gauges, CMM, and vision systems to verify specifications, interpreting blueprints and GD&T, conducting audits, and supporting continuous improvement while assuring compliance with ISO 13485, ISO 9001, GMP, and

Qualifications

• Experience in QA/QC in manufacturing, preferably medical devices.
• Knowledge of ISO 13485, ISO 9001, GMP, FDA regulations.
• Proficiency with precision measurement tools.
• Ability to read blueprints and GD&T.
• Familiarity with QA/QC processes and audits.
• Strong attention to detail and math skills.
• Good communication across teams.

Responsibilities

• Conduct dimensional measurements using height gauges, CMM, and vision systems to verify specifications.
• Perform quality inspections on raw materials, in-process components, and finished products.
• Interpret drawings and GD&T to assess product conformity.
• Execute quality audits and participate in internal QMS reviews.
• Collect and analyze data to support continuous improvement.
• Maintain calibration schedules for measuring instruments and ensure regulatory compliance.
• Support manufacturing teams by guidance on quality standards and root cause analysis.

Skills

Dimensional measurements

QA/QC procedures

Regulatory compliance

GD&T interpretation

Data analysis

Team collaboration

Tools

Height gauges

CMM

Vision inspection systems

Measurement data software

Job description

Description

Schedule: First Shift (6:00am – 2:30pm), Monday–Friday.

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.