Senior Quality Engineer - MedTech NPD & Compliance

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

Benefits offered by this job

Equal Opportunity Employer

Competitive compensation

Job summary

BD Irvine, CA is seeking a Sr. Quality Engineer to apply quality engineering principles to ensure regulatory compliance and robust product development across design, manufacturing, and distribution.

You will lead design assurance activities, develop risk management files, collaborate with R&D, manufacturing, and regulatory teams, and drive verification and validation tests, CAPA investigations, and data-driven process improvements.

Qualifications

• Bachelor's in Engineering or scientific field with 4+ years' experience.
• Master's in Engineering or scientific field with 2 years' experience.
• PhD or equivalent with 1 year of experience.
• Hands-on with Design Assurance, Design Controls, V&V, and design test methods.
• Experience in a highly regulated industry.

Responsibilities

• Leads design assurance and development activities for New Product Development programs.
• Provides engineering solutions in QA, Design Control, Risk Management, and statistics.
• Develop, update, and maintain risk management files.
• Collaborates cross-functionally with R&D, Manufacturing, and Regulatory.
• Develops and validates experiments and tests to improve products and processes.
• Investigates manufacturing quality and compliance issues prior to final release.
• Leads design verification activities and complex process improvements.
• Trains technicians and coordinates engineer work.
• Other duties assigned by leadership.

Skills

Quality Assurance

Design Controls

Risk Management

Statistical Techniques

Cross-functional Collaboration

Regulatory Compliance

Education

Bachelor's degree in Engineering

Master's degree in Engineering

PhD in Engineering

Tools

Statistical Software

Job description

BD Irvine, CA is seeking a Sr. Quality Engineer to apply quality engineering principles to ensure regulatory compliance and robust product development across design, manufacturing, and distribution.

You will lead design assurance activities, develop risk management files, collaborate with R&D, manufacturing, and regulatory teams, and drive verification and validation tests, CAPA investigations, and data-driven process improvements.