Lead Quality Engineer: Regulatory & Continuous Improvement

Katalyst CRO; Green Bay (WI); On-site; USD 130,000 - 190,000; Full time

Job summary

Katalyst CRO in Green Bay, WI seeks an experienced Principal Quality Engineer to lead quality initiatives across manufacturing and product development, ensuring compliance with FDA, ISO 13485, and cGMP standards.

You will provide technical leadership in quality systems, CAPA, risk management, validation, supplier quality, and audits while partnering with cross-functional teams to drive continuous improvement and operational excellence.

Qualifications

• Bachelor's degree in Engineering is required.
• 8+ years of Quality Engineering in a regulated manufacturing environment.
• Strong knowledge of FDA regulations, ISO 13485, ISO 9001, and cGMP.
• Experience with Design Controls, Risk Management (ISO 14971), CAPA, and change management.
• Hands-on process validation (IQ/OQ/PQ) and statistical analysis skills.

Responsibilities

• Lead quality engineering activities supporting product development and manufacturing.
• Develop and implement quality strategies compliant with FDA/ISO standards.
• Drive CAPA investigations and corrective actions using structured problem solving.
• Lead risk management activities including DFMEA, PFMEA, and mitigation planning.
• Review ECOs, design docs, validation protocols, and DHF entries.
• Support design controls and design reviews; ensure traceability in DHF.
• Analyze quality metrics and drive continuous improvement with Lean Six Sigma and SPC.
• Lead process validation efforts (IQ/OQ/PQ) and capability studies.
• Collaborate cross-functionally to resolve quality issues and prepare audits.

Skills

Quality systems

Regulatory compliance

CAPA processes

Risk management

Design controls

Root cause analysis

Education

Bachelor's degree in Engineering

Master's degree in Engineering

Tools

Minitab

QMS software

Job description

Katalyst CRO in Green Bay, WI seeks an experienced Principal Quality Engineer to lead quality initiatives across manufacturing and product development, ensuring compliance with FDA, ISO 13485, and cGMP standards.

You will provide technical leadership in quality systems, CAPA, risk management, validation, supplier quality, and audits while partnering with cross-functional teams to drive continuous improvement and operational excellence.