Senior Quality Engineer: Design Controls & Improvement

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

Job summary

Becton Dickinson 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, collaborate with R&D, manufacturing, and regulatory teams, and develop robust verification and validation strategies for new products and processes.

Qualifications

• Bachelor's degree in Engineering or Science with 4 years of related experience.
• Master's degree or equivalent with 2 years of related experience; PhD or equivalent with 1 year of related experience.
• Hands-on experience with Design Assurance, including Design Controls, Design Freeze, Verification/Validation, and/or Test Method Development.
• Experience in a highly regulated industry.

Responsibilities

• Lead design assurance and development activities for New Product Development programs.
• Provide QA solutions in Design Control, Risk Management, and Statistical Techniques.
• Develop and maintain risk management files.
• Collaborate cross-functionally to enable NPD and robust product launches.
• Develop and validate complex experiments and tests; analyze results and prepare reports.
• Investigate manufacturing quality and compliance issues across production processes.
• Lead design verification activities and continuous process improvement initiatives.
• Assign tasks and mentor technicians and junior engineers.

Skills

Quality engineering

Design controls

Risk management

Statistical techniques

Technical writing

Reading drawings

Six Sigma

Cross-functional collaboration

Education

Bachelor's degree in Engineering or Science

Master's degree or equivalent

Ph.D. or equivalent

Tools

Statistical software

Document control systems

Job description

Becton Dickinson 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, collaborate with R&D, manufacturing, and regulatory teams, and develop robust verification and validation strategies for new products and processes.