Lead Quality Engineer: Regulatory Compliance & Excellence

Katalyst CRO; Fort Smith (AR); On-site; USD 110,000 - 150,000; Full time

Job summary

Katalyst CRO seeks 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

Qualifications

• Experience in medical device quality engineering.
• Proven track record supporting FDA/ISO audits.

Responsibilities

• Lead quality engineering activities for product development, manufacturing, and sustaining engineering.
• Develop and implement quality strategies compliant with FDA, ISO 13485, ISO 9001.

Skills

Quality leadership

Regulatory compliance

CAPA & risk mgmt

DFMEA/PFMEA

V&V & DHR

Lean Six Sigma

Job description

Katalyst CRO seeks 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