Quality Tech in Columbia City, Indiana at QuikCut LLC

Job description:

Overview
We are seeking a highly motivated and detail-oriented Quality Technician to join our dynamic manufacturing team. In this role, you will be instrumental in ensuring that our products meet the highest quality standards by performing precise inspections, conducting thorough quality audits, and maintaining robust quality systems. Your expertise will help uphold compliance with industry regulations such as ISO 13485, FDA regulations, and ISO 9001, while supporting continuous improvement initiatives. This is an exciting opportunity for someone passionate about quality assurance and committed to delivering excellence in a fast-paced production environment.

Duties

• Perform detailed quality inspections using precision measuring instruments such as calipers, micrometers, vision inspection systems, and coordinate measuring machines to verify product dimensions and specifications.
• Conduct regular quality audits across manufacturing processes to identify areas for improvement and ensure adherence to ISO 13485, ISO 9001, CGMP (Current Good Manufacturing Practice), and HACCP standards.
• Collect and analyze data related to product quality, process performance, and non-conformance issues to support root cause analysis and corrective actions.
• Assist in the development, implementation, and maintenance of quality management systems (QMS) aligned with industry standards and regulatory requirements.
• Support calibration activities for precision measuring instruments and ensure all tools meet calibration standards.
• Participate in internal and external quality audits to verify compliance with FDA regulations and other applicable standards.
• Collaborate with manufacturing teams to resolve quality issues promptly, ensuring products meet specifications before shipment.

Requirements

• Proven experience in a manufacturing environment with a focus on quality control or quality assurance roles.
• Strong analysis skills with the ability to interpret data accurately and identify trends or deviations.
• Familiarity with calibration of precision measuring instruments such as calipers, micrometers, vision inspection systems, and coordinate measuring machines.
• Knowledge of industry standards including ISO 13485 (medical devices), ISO 9001 (quality management), FDA regulations, CGMP practices, and HACCP principles.
• Experience conducting quality audits and implementing corrective actions based on audit findings.
• Proficiency with quality systems software (e.g., Calypso or similar) is preferred.
• Excellent attention to detail combined with strong communication skills for reporting findings clearly and effectively.
• Ability to work independently or as part of a team in a fast-paced environment while maintaining high accuracy standards. Join us as a Quality Technician and be part of a dedicated team committed to excellence! Your expertise will drive continuous improvement initiatives that uphold our reputation for delivering safe, reliable products that meet rigorous industry standards.

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Vision insurance

Work Location: In person