Design Quality Engineer — Medical Devices & Compliance

Katalyst CRO; Bothell (WA); On-site; USD 110,000 - 150,000; Full time

Job summary

Philips is seeking a Design Quality Engineer to ensure products are designed and developed in compliance with regulatory standards and quality requirements. You will work with R&D, regulatory, manufacturing, and suppliers to embed quality into product design.

Responsibilities include design control, risk management, V&V activities, and design transfer to manufacturing, with a focus on ensuring traceability and adherence to FDA and ISO 13485 requirements.

Qualifications

• Experience in FDA regulated medical device environments is required.
• Proven ability to lead design quality activities across product life cycle.
• Knowledge of Design Control, risk management, and quality system processes.

Responsibilities

• Lead Design Control activities across product lifecycle.
• Participate in design planning, reviews, verification and validation.
• Ensure design inputs/outputs and documentation meet regulatory standards.
• Support traceability matrices and change control processes.
• Provide mentorship and align cross-functional teams with quality standards.
• Guide risk management and FMEA throughout development.
• Assist in design transfer to manufacturing and process readiness.
• Support audits, CAPA, and QMS processes.

Skills

Design Quality

Regulatory Compliance

Risk Management

Design Control

Change Management

Design Transfer

QMS

CAPA

FDA Regulations

ISO 13485

Education

Bachelor's Degree in Medical Sciences / Healthcare / Industrial Engineering or related

Job description

Philips is seeking a Design Quality Engineer to ensure products are designed and developed in compliance with regulatory standards and quality requirements. You will work with R&D, regulatory, manufacturing, and suppliers to embed quality into product design.

Responsibilities include design control, risk management, V&V activities, and design transfer to manufacturing, with a focus on ensuring traceability and adherence to FDA and ISO 13485 requirements.