Senior Quality Engineer, Regulatory & CAPA Expert

Katalyst CRO; Fort Smith (AR); On-site; USD 110,000 - 145,000; Full time

Job summary

Katalyst CRO in Fort Smith, AR is seeking a Principal Quality Engineer to lead quality initiatives across manufacturing and product development. You will provide technical leadership in quality systems, risk management, validation, CAPA, supplier quality and regulatory compliance while partnering with cross-functional teams to drive operational excellence.

The role emphasizes design controls, IQ/OQ/PQ, process validation and continuous improvement using Lean Six Sigma.

Qualifications

• Bachelor's degree in Engineering or related field required.
• 8+ years of Quality Engineering experience in regulated manufacturing.
• Experience with FDA, ISO 13485, ISO 9001 and cGMP requirements.

Responsibilities

• Lead quality engineering activities across product development and manufacturing.
• Develop quality strategies meeting regulatory requirements (FDA/ISO).
• Drive CAPA investigations and implement corrective actions.
• Lead risk management including DFMEA/PFMEA and risk mitigation.
• Review ECOs, design docs, validation protocols, and DHF records.
• Support design controls including V&V, design reviews, and DHF.
• Analyze quality metrics and drive continuous improvement (Lean Six Sigma).
• Lead IQ/OQ/PQ and process validation activities.
• Collaborate with Manufacturing, R&D, Regulatory Affairs, Supply Chain and Operations.
• Provide technical leadership during audits and mentor engineers.

Skills

Quality leadership

CAPA

Root cause analysis

Statistical analysis

Lean Six Sigma

Regulatory compliance

Design Controls

Cross-functional teamwork

Education

Bachelor's degree in Engineering

Master's degree in Engineering

Tools

Minitab

Job description

Katalyst CRO in Fort Smith, AR is seeking a Principal Quality Engineer to lead quality initiatives across manufacturing and product development. You will provide technical leadership in quality systems, risk management, validation, CAPA, supplier quality and regulatory compliance while partnering with cross-functional teams to drive operational excellence.

The role emphasizes design controls, IQ/OQ/PQ, process validation and continuous improvement using Lean Six Sigma.