Systems Design Quality Engineer: Validation & CAPA Lead

Philips; Bothell (WA); On-site; USD 90,000 - 140,000; Full time

Job summary

Philips is seeking a Systems Design Quality Engineer to drive design quality across product lifecycles in a healthcare context. You will lead validation, design control, and CAPA programs, collaborate with R&D, manufacturing, and regulatory teams, and ensure rigorous documentation and risk management practices.

The role emphasizes usability, reliability, privacy, and security considerations, with a focus on patient safety and regulatory compliance across design transfers and post-market

Qualifications

• Minimum required Education: Bachelor's / Master's Degree in Mechanical Engineering, Electronics Engineering, Science, or equivalent.
• Minimum required Experience: Minimum 2 years of experience with a Bachelor's degree in areas such as Quality Engineering, Safety Engineering, R&D Engineering, or equivalent OR no prior experience required with a Master's Degree.
• Preferred Certification: Six Sigma Green Belt

Responsibilities

• Develop and execute process validation strategies using statistical methodologies to ensure successful transfers of new products into manufacturing while meeting quality, regulatory, and business requirements.
• Lead and support Design Control activities, including design inputs, design reviews, verification, validation, and design transfer, ensuring compliance with applicable quality system and regulatory standards.
• Create, review, and maintain quality engineering documentation, including quality plans, risk management files, validation protocols and reports, and DHF documentation.
• Drive continuous product quality improvements by integrating quality, reliability, and PMS insights throughout the product lifecycle.
• Assess product and system designs, analyzing performance data, and conducting root cause investigations to identify, address, and prevent quality issues.
• Evaluate critical design requirements related to usability, reliability, performance, manufacturability, safety, privacy, and security to ensure products meet customer and regulatory expectations.
• Facilitate risk management activities across the product lifecycle, ensuring risks are effectively identified, assessed, controlled, and monitored to support patient safety and product quality.
• Leverage post-market performance data and customer feedback to identify opportunities for improvement and support corrective and preventive actions.
• Support internal and external audits, inspections, and compliance activities by maintaining audit-ready documentation and ensuring adherence to quality standards.
• Lead CAPA activities, including issue identification, root cause analysis, corrective action implementation, and effectiveness verification to drive sustainable improvements.
• Apply continuous improvement methodologies to enhance quality processes, strengthen compliance, and improve operational effectiveness.
• Collaborate with cross-functional teams including R&D, Manufacturing, Regulatory Affairs, and Quality to ensure successful project execution and high-quality product outcomes.
• Build strong relationships with internal and external stakeholders while providing quality guidance and mentorship to support project milestones and organizational objectives.

Skills

Design Quality Management

Data Analysis & Interpretation

Design for Quality

Root Cause Analysis

CAPA Methodologies

Regulatory Requirements

Privacy, Safety, and Security

Technical Documentation

Product Quality and Reliability

Design Validation Planning

Product Test Design

Education

Bachelor's / Master's Degree in Mechanical Engineering, Electronics Engineering, Science, or equivalent

Job description

Philips is seeking a Systems Design Quality Engineer to drive design quality across product lifecycles in a healthcare context. You will lead validation, design control, and CAPA programs, collaborate with R&D, manufacturing, and regulatory teams, and ensure rigorous documentation and risk management practices.

The role emphasizes usability, reliability, privacy, and security considerations, with a focus on patient safety and regulatory compliance across design transfers and post-market