Senior Quality Engineering Lead – Regulated Medical Devices

Katalyst CRO; Irvine (CA); On-site; USD 150,000 - 210,000; Full time

Job summary

Katalyst CRO in Irvine, CA is seeking a Principal Quality Engineer to lead quality initiatives in a highly regulated manufacturing environment. You will provide technical leadership for quality systems, CAPA, risk management, and validation programs to ensure products meet regulatory and customer requirements.

You will mentor quality engineers, drive root cause analyses, manage audits and supplier quality, and partner with R&D, regulatory affairs, and operations to drive continuous improvement

Qualifications

• Bachelor's degree in 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.

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

Statistical analysis

Regulatory compliance

Cross-functional collaboration

Risk management

Process improvement

Technical writing

Education

Bachelor's degree in Engineering

Master's degree in Engineering or related field

Tools

Minitab

SPC

DOE

FMEA

IQ/OQ/PQ

Job description

Katalyst CRO in Irvine, CA is seeking a Principal Quality Engineer to lead quality initiatives in a highly regulated manufacturing environment. You will provide technical leadership for quality systems, CAPA, risk management, and validation programs to ensure products meet regulatory and customer requirements.

You will mentor quality engineers, drive root cause analyses, manage audits and supplier quality, and partner with R&D, regulatory affairs, and operations to drive continuous improvement