Principal Quality Engineer: Regulatory Excellence & CI

Katalyst-Healthcares-; Birmingham (AL); On-site; USD 120,000 - 180,000; Full time

Job summary

Katalyst-Healthcares- seeks a Principal Quality Engineer to lead quality systems, risk management, and CAPA across manufacturing and product development. You will drive regulatory compliance with FDA/ISO standards, supervise audits, and mentor teams to achieve operational excellence.

The role emphasizes design controls, V&V activities, process validation, and data-driven continuous improvement using Lean Six Sigma and advanced statistical tools.

Qualifications

• Bachelor's degree in Engineering; 8+ years quality engineering in regulated manufacturing.
• Strong knowledge of FDA, ISO 13485, ISO 9001, and cGMP requirements.
• Experience with Design Controls, Risk Management (ISO 14971), CAPA, and change management.
• Hands-on with IQ/OQ/PQ, statistical analysis, SPC, MSA, and capability studies.
• Lean manufacturing, Six Sigma, and continuous improvement methodologies.
• Excellent root cause analysis using 8D, Fishbone, 5 Whys.

Responsibilities

• Lead quality engineering activities supporting product development, manufacturing, and sustaining engineering.
• Develop and implement quality strategies that comply with FDA, ISO standards.
• Drive CAPA investigations and corrective actions using structured problem-solving.
• Lead risk management activities including DFMEA, PFMEA, and mitigation plans.
• Review ECOs, design docs, validation protocols, and quality records.
• Support design controls including V&V, design reviews, and DHF.
• Analyze quality metrics and drive continuous improvement via Lean Six Sigma.
• Lead process validation activities: IQ, OQ, PQ, and capability studies.
• Collaborate across functions to resolve quality issues; assist audits and inspections.
• Mentor Quality Engineers and cross-functional teams on best practices.

Skills

Quality systems

Risk management

CAPA

Lean Six Sigma

Statistical tools

Root cause analysis

Auditing

Mentoring

Education

Bachelor's degree in Engineering

Master's degree in Engineering or related field

Tools

Minitab

Job description

Katalyst-Healthcares- seeks a Principal Quality Engineer to lead quality systems, risk management, and CAPA across manufacturing and product development. You will drive regulatory compliance with FDA/ISO standards, supervise audits, and mentor teams to achieve operational excellence.

The role emphasizes design controls, V&V activities, process validation, and data-driven continuous improvement using Lean Six Sigma and advanced statistical tools.