Jobs · Healthcare · Washington

Systems Design Quality Engineer

SSi People · Bothell, WA · 3 wk ago
HealthcareContract

About the role

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. The team seeks 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.

Requirements

  • 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.

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