Manufacturing Quality Engineer

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

Job Description

We are seeking a Manufacturing Quality Engineer to support manufacturing operations by ensuring products meet quality standards, regulatory requirements, and customer expectations. The ideal candidate will drive quality improvements, investigate non-conformances, lead root cause analysis activities, and collaborate with cross-functional teams to maintain a robust Quality Management System (QMS).

Job Description

We are seeking a Manufacturing Quality Engineer to support manufacturing operations by ensuring products meet quality standards, regulatory requirements, and customer expectations. The ideal candidate will drive quality improvements, investigate non-conformances, lead root cause analysis activities, and collaborate with cross-functional teams to maintain a robust Quality Management System (QMS).

Responsibilities

• Support daily manufacturing operations to ensure compliance with quality standards and procedures.
• Investigate product defects, non-conformances, deviations, and customer complaints.
• Lead root cause investigations using methodologies such as 5 Whys, Fishbone, Pareto Analysis, and FMEA.
• Develop, implement, and monitor Corrective and Preventive Actions (CAPA).
• Analyze quality metrics and identify opportunities for 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 Statistical Process Control (SPC) data and implement process improvements.
• Ensure compliance with applicable regulations and quality standards.
• Support risk management and quality planning activities.

Requirements

• Bachelor's degree in mechanical, Industrial, Manufacturing, Biomedical Engineering.
• 3+ years of experience in Quality Engineering, Manufacturing Quality, or Quality Assurance.
• Experience in a manufacturing environment.

Required Skills

• Quality Management Systems (QMS).
• CAPA Management.
• Root Cause Analysis.
• Non-Conformance Management.
• Change Control.
• Statistical Process Control (SPC).
• FMEA (Failure Mode and Effects Analysis).
• Risk Management.
• Process Improvement.
• Data Analysis and Reporting.
• Technical Documentation.

Preferred Qualifications

• Experience with:
• ISO 9001
• ISO 13485
• AS9100
• IATF 16949
• GMP/GxP environments
• Knowledge of Lean Manufacturing and Six Sigma methodologies.
• Experience with validation and qualification activities.
• ASQ certifications such as American Society for Quality CQE or CQA preferred.