Quality Team Lead: ISO/FDA CAPA & Precision QA

Gotion, Inc.; Manteno (IL); On-site; USD 30,000 - 42,000; Full time

Job summary

Gotion Inc. is seeking a Quality Team Lead to oversee daily quality operations at our Manteno, IL facility. You will guide Quality Inspectors, drive improvements, and ensure products meet customer specs and regulatory standards.

This role interfaces with Quality, Production, and Engineering to foster a culture of quality. Responsibilities include performing inspections with calipers, micrometers, and CMMs; leading audits per ISO 13485, ISO 9001, and FDA; and maintaining detailed inspection

Qualifications

• At least 2-3 years of quality experience in a production or manufacturing environment.
• At least 1 year of team lead or supervisor experience.
• Hands-on experience operating calipers, micrometers, vision inspection systems, and CMM.
• Demonstrated ability to analyze data accurately, identify trends, and recommend process improvements.
• Excellent attention to detail combined with strong communication for clear documentation and reporting.

Responsibilities

• Perform thorough inspections of products using precision measuring instruments to verify conformance to specifications.
• Utilize quality tools like Calypso and coordinate measuring machines (CMM) to gather accurate data during inspections.
• Conduct quality audits in accordance with ISO 13485, ISO 9001, and FDA regulations to ensure compliance.
• Document inspection results meticulously, including data collection and analysis, to support quality assurance initiatives.
• Identify non-conformances and collaborate with manufacturing teams to implement corrective actions aligned with CGMP and HACCP.
• Participate in root cause analysis and problem-solving activities to improve product quality and process efficiency.
• Support internal and external quality audits by providing detailed reports and maintaining records.

Tools

Calypso

CMM

Vision inspection systems

Calipers

Micrometers

Job description

Gotion Inc. is seeking a Quality Team Lead to oversee daily quality operations at our Manteno, IL facility. You will guide Quality Inspectors, drive improvements, and ensure products meet customer specs and regulatory standards.

This role interfaces with Quality, Production, and Engineering to foster a culture of quality. Responsibilities include performing inspections with calipers, micrometers, and CMMs; leading audits per ISO 13485, ISO 9001, and FDA; and maintaining detailed inspection