Quality Engineer

Katalyst CRO; DeLand (FL); On-site; USD 75,000 - 95,000; Full time

Job summary

Katalyst CRO is seeking a Quality Engineer to ensure high quality products and processes in our Florida manufacturing environment. The role involves audits, inspections, testing, data analysis, and driving continuous improvement alongside cross-functional teams.

Responsibilities include leading CAPA investigations, coordinating MRB activities, and reducing material scrap in collaboration with Production and Engineering. Strong QA tools knowledge and ISO 9001 experience are essential.

Qualifications

• Bachelor's degree or equivalent experience.
• Knowledge of ISO 9001 (current rev) and QMS standards.
• 5 years' experience in a Quality Engineering role.

Responsibilities

• Lead and coordinate customer quality complaint resolution with the manufacturing value stream for root cause investigation and CAPA, 8D reporting.
• Review CAPA from the manufacturing value stream to determine the robustness and effectiveness verifications.
• Work with the manufacturing value stream to implement QMS improvements and maintain documentation.
• Attend daily management (DM) activities to provide quality updates and input.
• Lead daily internal Material Review Board (MRB) activities and coordinate scrap review in the scrap marketplace.
• Drive material scrap reduction initiatives in collaboration with Production and Engineering teams.

Skills

Communication

Team collaboration

Continuous Improvement

Problem solving

Education

Bachelor's degree or equivalent experience

Tools

SPC

MSA

Pareto analysis

ANOVA

FMEA

Cause-and-Effect Diagram

8D reporting

Job description

Summary

The Quality Engineer ensures the consistent quality of products and processes through audits, inspections, testing, analysis, and continuous improvement activities. This role supports manufacturing and cross functional departments by conducting defect and trend analysis, troubleshooting, monitoring calibration, and reporting on results of measurement standards. The Quality Engineer also partners with suppliers and internal value streams to validate processes, support data interpretation, and reinforce adherence to Quality Management System (QMS) standards.

• Lead and coordinate customer quality complaint resolution with the manufacturing value stream for root cause investigation and CAPA, 8D reporting.
• Review CAPA from the manufacturing value stream to determine the robustness and effectiveness verifications.
• Work with the individual manufacturing value stream to implement QMS improvements and maintain documentation.
• Attend daily management (DM) activities to provide quality updates and input.
• Lead daily internal Material Review Board (MRB) activities and coordinate scrap review in the scrap marketplace.
• Drive material scrap reduction initiatives in collaboration with Production and Engineering teams.

Summary

The Quality Engineer ensures the consistent quality of products and processes through audits, inspections, testing, analysis, and continuous improvement activities. This role supports manufacturing and cross functional departments by conducting defect and trend analysis, troubleshooting, monitoring calibration, and reporting on results of measurement standards. The Quality Engineer also partners with suppliers and internal value streams to validate processes, support data interpretation, and reinforce adherence to Quality Management System (QMS) standards.

Roles & Responsibilities

• Lead and coordinate customer quality complaint resolution with the manufacturing value stream for root cause investigation and CAPA, 8D reporting.
• Review CAPA from the manufacturing value stream to determine the robustness and effectiveness verifications.
• Work with the individual manufacturing value stream to implement QMS improvements and maintain documentation.
• Attend daily management (DM) activities to provide quality updates and input.
• Lead daily internal Material Review Board (MRB) activities and coordinate scrap review in the scrap marketplace.
• Drive material scrap reduction initiatives in collaboration with Production and Engineering teams.

Qualifications

• Bachelor's degree or equivalent experience.
• Knowledge of ISO 9001, (current rev) to aid in maintaining QMS
• 5 years' experience in a Quality Engineering role.
• Working knowledge in statistical tools (such as SPC, MSA, Pareto, ANOVA etc.) and quality tools (such as FMEA, Cause and Effect Diagram, 8D etc.).
• Proficient in software such as Microsoft Office, SAP, Pilgrim/Smart Solve
• Exceptional communication skills, Ability to interact with all areas, Team player.
• Continuous Improvement Activities, Lean Manufacturing Principles, 5S, Kaizen
• Drive material scrap reduction initiatives in collaboration with Production and Engineering teams.