Systems Design Quality Engineer

SSi People; Bothell (WA); Hybrid; USD 110,000 - 150,000; Full time

Job summary

SSi People in Bothell, WA seeks a Systems Design Quality Engineer to ensure product quality and compliant design transfer from development to production.

The role emphasizes validation, risk management, and rigorous documentation to support audit readiness and continuous improvement in a hybrid work setting.

Qualifications

• Bachelor's or Master's degree in Mechanical Engineering, Electronics Engineering, Science, or an equivalent field.
• Minimum 5+ years of experience with a Bachelor's degree in Quality Engineering, Safety Engineering, R&D Engineering, or an equivalent area, or no prior experience required with a Master's degree.
• Experience with design quality management, data analysis and interpretation, DFQ, RCA, CAPA methodologies, regulatory requirements, privacy, safety, and security risk assessment, technical documentation, continuous improvement, product quality and reliability, defect management, design verification planning, design validation planning, and product test design.
• Preferred certification: Six Sigma Green Belt.

Responsibilities

• Develop and execute comprehensive process validation strategies using statistical tools to support new product transitions into production.
• Lead design control activities from defining and validating design inputs through verification, validation, and design transfer.
• Maintain accurate quality engineering documentation, including quality plans for hardware, software, and systems.
• Support quality improvement efforts by applying quality, reliability, and post-market surveillance insights, while conducting root cause analysis and supporting corrective actions.

Skills

Design for Quality

Root Cause Analysis

CAPA Methodologies

Data Analysis

Documentation

Education

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

Job description

Job Title: Systems Design Quality Engineer

Location: Bothell, Washington (Hybrid)

Job Summary: We are supporting a search for a Systems Design Quality Engineer with a focus on driving product quality, compliance, and smooth design transfer from development into production. Our team is looking for a professional who can strengthen validation, risk management, and continuous improvement efforts while helping maintain audit readiness and rigorous documentation practices.

Responsibilities

• Develop and execute comprehensive process validation strategies using statistical tools to support new product transitions into production.
• Lead design control activities from defining and validating design inputs through verification, validation, and design transfer.
• Maintain accurate quality engineering documentation, including quality plans for hardware, software, and systems.
• Support quality improvement efforts by applying quality, reliability, and post-market surveillance insights, while conducting root cause analysis and supporting corrective actions.

Required

• Bachelor's or Master's degree in Mechanical Engineering, Electronics Engineering, Science, or an equivalent field.
• Minimum 5+ years of experience with a Bachelor's degree in Quality Engineering, Safety Engineering, R&D Engineering, or an equivalent area, or no prior experience required with a Master's degree.
• Experience with design quality management, data analysis and interpretation, design for quality (DFQ), root cause analysis (RCA), CAPA methodologies, regulatory requirements, privacy, safety, and security risk assessment, technical documentation, continuous improvement, product quality and reliability, defect management, design verification planning, design validation planning, and product test design.
• Preferred certification: Six Sigma Green Belt.

About SSI People

With over 26 years of industry experience, SSi People has built its reputation and expertise on putting people first. Everything we do works toward delivering exceptional experience for our consultants, our clients, and our internal team. Through a genuine commitment to people in everything we do. We have developed refined processes and a stellar internal team to deliver talent quickly. More importantly, we focus on building long-term relationships, not transactions. Putting people first is just what we do well.