Senior Quality Engineer: Lead Design Controls & Compliance

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

Job summary

BD in Irvine, CA is seeking a Sr. Quality Engineer to apply quality engineering principles, 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 drive robust design verification and process improvements. The role requires hands-on experience with Design Controls, Risk Management, and statistical techniques within a highly regulated medical device

Qualifications

• Bachelor's/Master's/PhD in Engineering or Science with relevant experience.
• Hands-on experience with Design Assurance including Design Controls and Verification/Validation.
• Experience in a highly regulated industry such as medical devices.

Responsibilities

• Leads design assurance and development activities for New Product Development programs.
• Provides engineering solutions in Quality Assurance, Design Control, Risk Management, and Statistical Techniques.
• Develops and maintains risk management files and collaborates cross-functionally to support NPD and launch of robust products.
• Investigates complex quality and compliance issues across production processes prior to final release.
• Leads design verification activities and optimization of manufacturing processes using Six Sigma and Lean tools.

Skills

Design Assurance

Design Controls

Risk Management

Statistical Techniques

Quality Systems

Education

Bachelor's degree in Engineering or Science

Master's degree in Engineering or Science

PhD in Engineering or Science

Job description

BD in Irvine, CA is seeking a Sr. Quality Engineer to apply quality engineering principles, 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 drive robust design verification and process improvements. The role requires hands-on experience with Design Controls, Risk Management, and statistical techniques within a highly regulated medical device