Design Quality Engineer

Job overview

The Design Quality Engineer role is onsite in San Diego, CA. Compensation is not specified. The role supports product design and development at Philips, working with R&D, regulatory, manufacturing, and suppliers to embed quality into product design. The engineer ensures products meet regulatory standards, quality requirements, and customer expectations throughout the product lifecycle. The work includes design controls, risk management, quality audits, corrective actions, and transfer to manufacturing.

What you'll do

• Ensure design-control compliance with 21 CFR Part 820 and ISO 13485
• participate in design planning, reviews, and verification/validation
• review design inputs, outputs, and technical documentation
• maintain traceability records
• review engineering changes
• support design transfer
• guide risk management, FMEA, and hazard analysis
• support audits and inspections
• manage CAPA and contribute to QMS processes.

What we're looking for

Skills & competencies

design quality engineer

philips

san diego ca

onsite

medical devices

design control

iso 13485

21 cfr part 820

risk management

fmea

capa

Work arrangement

• Weekend coverage required

Why this role

Requires a bachelor’s degree in a listed or equivalent field and at least 5 years of experience in FDA-regulated medical device environments focused on design assurance/control and risk. Knowledge of medical-device regulations and standards is required.

About the employer

Karwell Technologies is hiring for this role. Industry: Engineering Services. Sector: 54.