Principal Quality Engineer - CAPA, Validation & QMS

Katalyst CRO; Fort Smith (AR); On-site; USD 105,000 - 165,000; Full time

Job summary

Katalyst CRO is seeking a Principal Quality Engineer to lead comprehensive quality initiatives across manufacturing and product development. You will drive quality systems, risk management, and validation activities, partnering with cross-functional teams to ensure regulatory compliance and product excellence.

Responsibilities include leading CAPA programs, audits, design control activities, and process validation using Lean Six Sigma tools to enable continuous improvement and robust quality.

Responsibilities

• Lead CAPA programs and audits
• Drive design control activities and process validation
• Implement Lean Six Sigma tools to enable continuous improvement and robust quality
• Develop and manage quality systems, risk management, and regulatory compliance across manufacturing and product development

Job description

Katalyst CRO is seeking a Principal Quality Engineer to lead comprehensive quality initiatives across manufacturing and product development. You will drive quality systems, risk management, and validation activities, partnering with cross-functional teams to ensure regulatory compliance and product excellence.

Responsibilities include leading CAPA programs, audits, design control activities, and process validation using Lean Six Sigma tools to enable continuous improvement and robust quality.