Senior Quality Engineer: Design Controls & Innovation

Becton Dickinson NA; Irvine (CA); On-site; USD 106,000 - 169,000; Full time

Job summary

Becton, Dickinson and Company in Irvine, CA is seeking a Sr. Quality Engineer to apply quality engineering principles to ensure regulatory compliance and optimize product development, manufacturing, and distribution.

You will lead design assurance activities, support risk management, statistical methods, and cross‑functional collaboration with R&D, manufacturing and regulatory to drive robust new products and continuous improvement.

Qualifications

• Bachelor's degree in engineering or scientific field; 4 years' experience in regulated environment.
• Master's degree or higher; 2+ years' experience in regulated environment.
• PhD or equivalent; 1+ year in regulated environment.

Responsibilities

• Leads design assurance and development activities for New Product Development programs.
• Provides engineering solutions in QA, design control, risk management, and statistics.
• Develops and maintains risk management files; ensures regulatory compliance across product lifecycle.

Skills

Quality Assurance

Design Control

Risk Management

Statistical Techniques

Design Verification & Validation

CAPA

Lean/Six Sigma

Regulatory Knowledge

Education

Bachelor's Degree in Engineering or Science

Master's Degree in Engineering or Science

Ph.D. in Engineering or Science

Tools

None

Job description

Becton, Dickinson and Company in Irvine, CA is seeking a Sr. Quality Engineer to apply quality engineering principles to ensure regulatory compliance and optimize product development, manufacturing, and distribution.

You will lead design assurance activities, support risk management, statistical methods, and cross‑functional collaboration with R&D, manufacturing and regulatory to drive robust new products and continuous improvement.