Quality Engineering Lead, Failure Analysis & CAPA

BD; Irvine (CA); On-site; USD 165,000 - 263,000; Full time

Job summary

BD in Irvine, CA is seeking a Senior Quality Manager, Failure Analysis to lead a team of engineers and technicians in thorough investigations of product failures, identify root causes, and implement corrective actions to ensure reliability and quality.

This role requires 8+ years in medical device failure analysis, Six Sigma and LEAN experience, strong data analytics, and proven leadership to guide cross-functional teams and drive continuous improvement across the development and manufacturing

Qualifications

• Bachelor's degree in engineering required.
• 8+ years in medical device failure analysis and data-driven quality
• Experience leading technical teams and CAPA programs
• Knowledge of SIX Sigma, LEAN, and regulatory standards

Responsibilities

• Lead investigations of product failures and determine root causes.
• Develop and implement CAPA and corrective actions.
• Manage cross-functional teams and budgets as applicable.
• Drive continuous improvement in product reliability and quality.

Skills

Six Sigma Certification

Project Leadership

Data Analysis

Quality Engineering

Regulatory Knowledge (FDA/ISO)

Microsoft Office

Education

Bachelor's Degree in Engineering

Tools

Failure Analysis Tools

Statistical Methods

Job description

BD in Irvine, CA is seeking a Senior Quality Manager, Failure Analysis to lead a team of engineers and technicians in thorough investigations of product failures, identify root causes, and implement corrective actions to ensure reliability and quality.

This role requires 8+ years in medical device failure analysis, Six Sigma and LEAN experience, strong data analytics, and proven leadership to guide cross-functional teams and drive continuous improvement across the development and manufacturing