Senior Quality Engineer: Failure Analysis & CAPA Lead

Hardware FYI; Irvine (CA); On-site; USD 106,000 - 169,000; Full time

Benefits offered by this job

Medical insurance

Dental & vision

401(k) with match

Paid time off

Life & disability insurance

Employee assistance program

Job summary

BD is a leading medical technology company seeking a Quality Engineer focused on failure analysis in Irvine, CA. You will lead investigations, apply structured problem-solving methods, and communicate findings to cross-functional teams.

The role emphasizes CAPA, regulatory compliance, and continuous improvement to enhance product reliability. Ideal candidates have 5+ years in quality engineering for medical devices, strong analytical skills, and familiarity with FDA/ISO standards.

Qualifications

• Bachelor's degree in engineering or related technical field; master's preferred.
• Minimum of 5 years in a quality/Failure Analysis role within medical devices.
• Expertise in FMEA, 8D, Ishikawa, microscopy, FTIR, SEM/EDX, X-ray.
• Strong knowledge of FDA 21 CFR Part 820, ISO 13485, MDR.
• Able to lead complex investigations and present data-driven conclusions.
• Excellent written and verbal communication with diverse audiences.
• Proficient in statistical analysis software and tools.
• ASQ CQE/CRE and Six-Sigma Black Belt are pluses.

Responsibilities

• Lead and conduct failure analysis investigations on returned products and complaints.
• Perform root cause analysis using structured methodologies (8D, 5-Why, FMEA).
• Develop and execute investigation plans to identify failure mechanisms.
• Use lab equipment and characterization techniques to evaluate performance.
• Author comprehensive technical reports with methods, findings and recommendations.
• Support complaint handling investigations and identify recurring failure modes.
• Analyze data to identify quality and reliability improvement opportunities.
• Collaborate with cross-functional teams to implement CAPA.
• Support reliability testing, design verification and validation activities.
• Participate in risk management, design FMEA and regulatory inspections.

Skills

Failure analysis

Root cause analysis

8D, 5-Why, Fishbone, FMEA

Statistical analysis

Communication skills

Regulatory knowledge

Independent & cross-functional work

Education

Bachelor's degree in Engineering

Master's degree preferred

ASQ CQE

CRE

Six-Sigma Black Belt

Tools

Microscopy

FTIR

SEM/EDX

X-ray

DPA

Job description

BD is a leading medical technology company seeking a Quality Engineer focused on failure analysis in Irvine, CA. You will lead investigations, apply structured problem-solving methods, and communicate findings to cross-functional teams.

The role emphasizes CAPA, regulatory compliance, and continuous improvement to enhance product reliability. Ideal candidates have 5+ years in quality engineering for medical devices, strong analytical skills, and familiarity with FDA/ISO standards.