Principal Quality Engineer

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

We are seeking an experienced Principal Quality Engineer to lead quality engineering initiatives that ensure compliance, product quality, and continuous improvement across manufacturing and product development processes. The ideal candidate 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.

Responsibilities

• Lead quality engineering activities supporting product development, manufacturing, and sustaining engineering.
• Develop and implement quality strategies that comply with FDA, ISO 13485, ISO 9001, and other applicable regulatory requirements.
• Drive root cause investigations and corrective and preventive actions (CAPA) using structured problem-solving methodologies.
• Lead risk management activities including DFMEA, PFMEA, risk assessments, and mitigation plans.
• Review and approve engineering change orders (ECOs), design documentation, validation protocols, and quality records.
• Support design control activities including Design Verification & Validation (V&V), Design Reviews, and Design History Files (DHF).
• Analyze quality metrics and implement continuous improvement initiatives using Lean Six Sigma and statistical tools.
• Lead process validation activities including IQ, OQ, PQ, and process capability studies.
• Collaborate with Manufacturing, R&D, Regulatory Affairs, Supply Chain, and Operations to resolve quality issues.
• Provide technical leadership during internal, customer, and regulatory audits.```json” ```json {