Manufacturing Quality Engineer — Lead CAPA & Root Cause

Katalyst CRO; Omaha (NE); On-site; USD 75,000 - 110,000; Full time

Job summary

Katalyst CRO is seeking a Manufacturing Quality Engineer to support our manufacturing operations by ensuring products meet quality standards, regulatory requirements, and customer expectations. The role focuses on driving quality improvements, investigating non-conformances, and leading root cause analyses within a robust QMS.

You will collaborate with cross-functional teams, develop CAPAs, monitor SPC data, review procedures, and contribute to audits and change control activities to sustain

Qualifications

• Bachelors degree in Mechanical, Industrial, Manufacturing, or Biomedical Engineering.
• 3+ years of experience in Quality Engineering, Manufacturing Quality, or Quality Assurance.
• Experience in a manufacturing environment.

Responsibilities

• Support daily manufacturing operations to ensure quality standards and procedures.
• Investigate product defects, non-conformances, deviations, and customer complaints.
• Lead root cause investigations using 5 Whys, Fishbone, Pareto Analysis, and FMEA.
• Develop, implement, and monitor CAPA programs.
• Analyze quality metrics for opportunities and continuous improvement.
• Review and approve manufacturing procedures, work instructions, SOPs, and quality documentation.
• Support process validation, equipment qualification, and change control activities.
• Conduct internal audits and participate in customer, regulatory, and certification audits.
• Collaborate with Manufacturing, Engineering, Supply Chain, Operations, and Quality teams.
• Monitor SPC data and drive process improvements.
• Ensure compliance with applicable regulations and quality standards.
• Support risk management and quality planning activities.

Skills

QMS

CAPA Management

Root Cause Analysis

Non-Conformance Management

Change Control

SPC

FMEA

Risk Management

Process Improvement

Data Analysis

Technical Documentation

Education

Bachelor's degree in Mechanical, Industrial, Manufacturing, Biomedical Engineering

Job description

Katalyst CRO is seeking a Manufacturing Quality Engineer to support our manufacturing operations by ensuring products meet quality standards, regulatory requirements, and customer expectations. The role focuses on driving quality improvements, investigating non-conformances, and leading root cause analyses within a robust QMS.

You will collaborate with cross-functional teams, develop CAPAs, monitor SPC data, review procedures, and contribute to audits and change control activities to sustain