Senior Quality Engineer: Failure Analysis & CAPA Lead

Becton Dickinson; Irvine (CA); On-site; USD 110,000 - 150,000; Full time

Job summary

BD Irvine is seeking a Senior Quality Engineer focused on failure analysis to investigate complaints and nonconformances across medical devices. You will apply 8D, 5-Why, FMEA, and microscopy to identify root causes and drive CAPAs.

You will collaborate with cross-functional teams, document findings for regulatory inspections, and help improve product quality in a fast-paced environment compliant with ISO 13485 and FDA requirements.

Qualifications

• Bachelor's degree in Engineering or related technical field; Master's preferred.
• 5+ years in a quality engineering role with failure analysis in medical devices.
• Expertise in FMEA, 8D, Ishikawa, microscopy, FTIR, SEM/EDX, DPA, X-ray.
• Knowledge of FDA 21 CFR Part 820, ISO 13485, MDR is desired.
• Strong communication and data-driven conclusions; problem-solving mindset.

Responsibilities

• Lead and conduct failure analysis investigations on returned products, customer complaints, manufacturing nonconformances, and reliability test failures.
• Perform root cause analysis using structured methodologies including 8D, 5-Why, Fishbone, FMEA.
• Develop and execute investigation plans to identify failure mechanisms and validate root causes.
• Use laboratory equipment, analytical tools, and characterization techniques to evaluate product performance and failure modes.
• Author comprehensive technical reports that clearly communicate methods, evidence, findings, conclusions, and recommendations.
• Support complaint handling investigations and provide technical assessments to identify recurring and emerging failure modes.
• Analyze data to identify opportunities for quality and reliability improvement.
• Partner with cross-functional teams to develop, implement, and verify CAPA.
• Support reliability testing, design verification and validation activities, and product robustness assessments.
• Participate in risk management activities, including design FMEA and reliability assessments.
• Recommend design, process, and quality improvements based on investigations.
• Support regulatory inspections, internal audits, and customer inquiries related to product investigations.
• Contribute to development and continuous improvement of failure analysis methods and lab capabilities.
• Present technical findings at cross-functional and management reviews.

Skills

Failure analysis

Root cause analysis

8D problem solving

5-Why

FMEA

Statistical analysis

Cross-functional collaboration

Technical report writing

Education

Bachelor's degree in Engineering

Master's degree preferred

Tools

FTIR

SEM/EDX

Microscopy

X-ray

Statistics software

Job description

BD Irvine is seeking a Senior Quality Engineer focused on failure analysis to investigate complaints and nonconformances across medical devices. You will apply 8D, 5-Why, FMEA, and microscopy to identify root causes and drive CAPAs.

You will collaborate with cross-functional teams, document findings for regulatory inspections, and help improve product quality in a fast-paced environment compliant with ISO 13485 and FDA requirements.