Principal Quality Engineer - Regulated Manufacturing Lead

Katalyst CRO; Baltimore (MD); On-site; USD 120,000 - 180,000; Full time

Job summary

Katalyst CRO is seeking an experienced Principal Quality Engineer to lead quality programs across manufacturing and product development. You will shape quality systems, risk management, validation, and CAPA, partnering with R&D, Regulatory Affairs, and Operations to drive compliance and excellence.

You will oversee design controls, V&V, IQ/OQ/PQ, process validation, supplier quality, and audits, while mentoring teams and guiding continuous improvement using Lean Six Sigma and statistical tools.

Qualifications

• Bachelor's degree in Engineering required.
• 8+ years of quality engineering experience in regulated manufacturing.
• Strong knowledge of FDA regulations, ISO 13485, ISO 9001, and cGMP.
• Experience with design controls, risk management (ISO 14971), CAPA, client, and change management.
• Hands-on process validation (IQ/OQ/PQ), statistical analysis, SPC, MSA, and capability studies.
• Strong knowledge of Lean Manufacturing, Six Sigma, and continuous improvement methodologies.
• Excellent root cause analysis skills utilizing 8D, Fishbone, 5 Whys, and similar tools.

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 regulatory requirements.
• Drive root cause investigations and CAPA using structured problem-solving methodologies.
• Lead risk management activities including DFMEA, PFMEA, risk assessments, and mitigation plans.
• Review and approve ECOs, design documentation, validation protocols, and quality records.
• Support design control activities including V&V, Design Reviews, and 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 audits.
• Mentor and coach Quality Engineers and cross-functional teams on quality best practices.
• Support supplier qualification, supplier audits, and supplier quality improvement initiatives.
• Ensure compliance with cGMP, FDA QSR (21 CFR Part 820) and international standards.

Skills

Root cause analysis

Cross-functional leadership

Project management

Problem solving

Education

Bachelor's degree in Engineering

Master's degree in Engineering

ASQ Certified Quality Engineer (CQE)

Six Sigma Green Belt or Black Belt

Tools

Minitab

Job description

Katalyst CRO is seeking an experienced Principal Quality Engineer to lead quality programs across manufacturing and product development. You will shape quality systems, risk management, validation, and CAPA, partnering with R&D, Regulatory Affairs, and Operations to drive compliance and excellence.

You will oversee design controls, V&V, IQ/OQ/PQ, process validation, supplier quality, and audits, while mentoring teams and guiding continuous improvement using Lean Six Sigma and statistical tools.