Quality Engineer

Katalyst CRO; DeLand (FL); On-site; USD 70,000 - 90,000; Full time

Job summary

Katalyst CRO in DeLand, Florida, is searching for a Quality Engineer to ensure product quality through audits, inspections, and continuous improvement. The role emphasizes collaboration with suppliers and internal teams to maintain and enhance Quality Management System standards.

The ideal candidate will have at least 5 years of experience, a relevant Bachelor's degree, and proficiency in statistical and quality tools. Strong communication skills and the ability to work across departments are essential for this role.

Qualifications

• 5 years' experience in a Quality Engineering role.
• Knowledge of ISO 9001 to aid in maintaining QMS.
• Proficient in statistical and quality tools.

Responsibilities

• Lead and coordinate customer quality complaint resolution.
• Review CAPA for robustness and effectiveness.
• Drive material scrap reduction initiatives.

Skills

Quality Engineering

Statistical Process Control (SPC)

Lean Manufacturing

Communication Skills

Education

Bachelor's degree or equivalent experience

Tools

Microsoft Office

SAP

Pilgrim/Smart Solve

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.

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.