Principal Quality Engineer: Lead in Regulated Manufacturing QA

Katalyst CRO; Birmingham (AL); On-site; USD 120,000 - 160,000; Full time

Job summary

Katalyst CRO is seeking an experienced Principal Quality Engineer to lead quality initiatives across manufacturing and product development, ensuring regulatory compliance and product quality. You will shape quality systems, risk management, CAPA, supplier quality, and audit readiness in collaboration with cross-functional teams.

The ideal candidate has 8+ years in quality engineering within regulated environments, deep FDA/ISO knowledge, hands-on validation experience, and proven leadership in

Qualifications

• 8+ years of quality engineering in a regulated manufacturing environment.
• Bachelor's degree in Engineering.
• Strong knowledge of FDA regulations, ISO 13485, ISO 9001, and cGMP requirements.
• Experience with Design Controls, Risk Management (ISO 14971), CAPA, client, and change management.
• Hands-on experience with 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.
• Experience leading cross-functional projects and mentoring engineering teams.

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 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 Design Verification & Validation (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 internal, customer, and regulatory 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 Quality System Regulation (21 CFR Part 820/QMSR), and applicable international standards.

Skills

Quality engineering

Regulatory knowledge

Root cause analysis

Lean Six Sigma

Cross-functional collaboration

Education

Bachelor's degree in Engineering

Master's degree (preferred)

Tools

Minitab

Job description

Katalyst CRO is seeking an experienced Principal Quality Engineer to lead quality initiatives across manufacturing and product development, ensuring regulatory compliance and product quality. You will shape quality systems, risk management, CAPA, supplier quality, and audit readiness in collaboration with cross-functional teams.

The ideal candidate has 8+ years in quality engineering within regulated environments, deep FDA/ISO knowledge, hands-on validation experience, and proven leadership in