Quality Engineer, Medical Devices & Design Controls

Becton Dickinson; San Diego (CA); On-site; USD 130,000 - 207,000; Full time

Job summary

Becton, Dickinson and Company in San Diego, CA is seeking a Quality Engineer to support new product development and ongoing maintenance of medical devices. You will apply quality engineering skills across design controls, risk management, and regulatory compliance to ensure products meet all standards.

You will collaborate with engineering, manufacturing, purchasing, regulatory affairs, and technical service to investigate CAPAs, conduct root cause analyses, develop test methods, and prepare

Qualifications

• Requires Master’s degree in Engineering or related field with 2 years of work experience in quality engineering for medical devices.
• Experience with design controls, ISO 13485 and risk management (ISO 14971).
• Familiar with FMEA, CAPA, data analysis and verification/validation concepts.

Responsibilities

• Review non-conformances from suppliers and manufacturing; assess impact on product quality.
• Develop test methods and sampling plans; design experiments and analyze data.
• Participate in FDA inspections; coordinate Notified Body audits; conduct internal audits.
• Support product launches and transitions from development to manufacturing.
• Lead root cause investigations; initiate corrective actions and verify effectiveness.

Skills

Statistical analysis

FMEA

Root Cause Analysis

ISO 13485

Quality tools

21 CFR Part 820.30 knowledge

Education

Master’s degree in Engineering

Bachelor’s degree in Engineering with 5 years experience

Tools

TeamCenter

Polarion

AzureDevOps

Job description

Becton, Dickinson and Company in San Diego, CA is seeking a Quality Engineer to support new product development and ongoing maintenance of medical devices. You will apply quality engineering skills across design controls, risk management, and regulatory compliance to ensure products meet all standards.

You will collaborate with engineering, manufacturing, purchasing, regulatory affairs, and technical service to investigate CAPAs, conduct root cause analyses, develop test methods, and prepare