Principal Quality Engineer

Katalyst CRO; Irvine (CA); On-site; USD 170,000 - 210,000; Full time

Job summary

Katalyst CRO in Irvine, CA seeks a Principal Quality Engineer to lead quality initiatives in a highly regulated manufacturing environment. You will provide technical leadership for quality systems, risk management, CAPA activities, process validation, and compliance programs, partnering with cross-functional teams to ensure products meet customer, regulatory, and business requirements.

The role emphasizes driving continuous improvement and operational excellence, reviewing validation protocols,

Qualifications

• Bachelor's degree in engineering or related technical field.
• Extensive quality engineering experience in highly regulated industries.
• Strong knowledge of FDA 21 CFR Part 820, ISO 13485, ISO 14971, GMP.
• Experience with CAPA, investigations, risk management, and process validation.
• Experience leading audits and interacting with regulatory agencies.
• Strong statistical analysis and problem-solving skills.
• Proficiency with quality tools including Minitab, SPC, DOE, FMEA, Control Plans, and Risk Assessments.
• Excellent technical writing, communication, and leadership skills.

Responsibilities

• Provide technical leadership and mentorship to Quality Engineers and cross-functional teams.
• Lead complex investigations involving customer complaints, nonconformances, deviations, and product quality issues.
• Drive root cause analysis using methodologies such as 8D, Fishbone, 5 Whys, Fault Tree Analysis, and FMEA.
• Lead CAPA development, implementation, effectiveness verification, and closure activities.
• Ensure compliance with FDA regulations, ISO 13485, ISO 14971, GMP, and other applicable quality standards.
• Support product development activities including Design Controls, Risk Management, Verification & Validation, and Design Transfer.
• Develop and maintain quality plans, inspection strategies, control plans, and quality metrics.
• Analyze quality trends and manufacturing data to identify opportunities for process improvement and risk reduction.
• Lead internal and external audits, supplier audits, and regulatory inspections.
• Collaborate with Manufacturing, R&D, Operations, Regulatory Affairs, and Supply Chain teams to resolve quality issues.
• Review and approve validation protocols and reports including IQ, OQ, PQ, TMV, and process validations.
• Support supplier quality management activities including supplier qualification and performance monitoring.
• Drive continuous improvement projects utilizing Lean, Six Sigma, and statistical process control methodologies.
• Review engineering changes and assess quality and regulatory impacts.
• Present quality performance metrics and recommendations to senior management.

Skills

Quality leadership

Root cause analysis

CAPA management

Design Controls

Risk Management (ISO 14971)

Process Validation

Statistical Analysis

Regulatory Compliance (FDA, ISO 13485)

Education

Bachelor's degree in engineering or related field

Master's degree (preferred)

Tools

Minitab

SPC

Job description

We are seeking a highly experienced Principal Quality Engineer to lead quality engineering initiatives in a regulated manufacturing environment. This role provides technical leadership for quality systems, product quality improvements, risk management, CAPA activities, process validation, and compliance programs. The Principal Quality Engineer serves as a subject matter expert, partnering with cross-functional teams to ensure products meet customer, regulatory, and business requirements while driving continuous improvement and operational excellence.

Responsibilities

• Provide technical leadership and mentorship to Quality Engineers and cross-functional teams.
• Lead complex investigations involving customer complaints, nonconformances, deviations, and product quality issues.
• Drive root cause analysis using methodologies such as 8D, Fishbone, 5 Whys, Fault Tree Analysis, and FMEA.
• Lead CAPA development, implementation, effectiveness verification, and closure activities.
• Ensure compliance with FDA regulations, ISO 13485, ISO 14971, GMP, and other applicable quality standards.
• Support product development activities including Design Controls, Risk Management, Verification & Validation, and Design Transfer.
• Develop and maintain quality plans, inspection strategies, control plans, and quality metrics.
• Analyze quality trends and manufacturing data to identify opportunities for process improvement and risk reduction.
• Lead internal and external audits, supplier audits, and regulatory inspections.
• Collaborate with Manufacturing, R&D, Operations, Regulatory Affairs, and Supply Chain teams to resolve quality issues.
• Review and approve validation protocols and reports including IQ, OQ, PQ, TMV, and process validations.
• Support supplier quality management activities including supplier qualification and performance monitoring.
• Drive continuous improvement projects utilizing Lean, Six Sigma, and statistical process control methodologies.
• Review engineering changes and assess quality and regulatory impacts.
• Present quality performance metrics and recommendations to senior management.

Requirements

• Bachelor's degree in engineering, Quality, Biomedical Engineering, Mechanical Engineering, Manufacturing Engineering, or related technical field.
• 815+ years of quality engineering experience in Medical Device, Pharmaceutical, Biotechnology, Aerospace, or highly regulated industries.
• Strong knowledge of FDA 21 CFR Part 820, ISO 13485, ISO 14971, GMP, and quality management systems.
• Extensive experience with CAPA, complaint handling, investigations, risk management, and process validation.
• Experience leading audits and interacting with regulatory agencies.
• Strong statistical analysis and problem-solving skills.
• Proficiency with quality tools including Minitab, SPC, DOE, FMEA, Control Plans, and Risk Assessments.
• Excellent technical writing, communication, and leadership skills.

Preferred Qualifications

• Master's degree in engineering or related field.
• ASQ Certifications such as:
• Certified Quality Engineer (CQE)
• Certified Six Sigma Black Belt (CSSBB)
• Certified Manager of Quality/Organizational Excellence (CMQ/OE)
• Experience with medical device product lifecycle management.
• Experience supporting global manufacturing operations.

Key Skills

• Quality Systems Management.
• CAPA Leadership.
• Root Cause Analysis.
• Design Controls.
• Risk Management (ISO 14971).
• Process Validation.
• Statistical Analysis.
• Supplier Quality.