Systems Design Quality Engineer

Elyon International•Bothell, WA

About The Position

The Systems Design Quality Engineer will be responsible for creating and executing comprehensive process validation strategies, managing the entire design control process, and ensuring rigorous adherence to regulatory and quality standards. This role involves drafting and updating quality engineering documents, leading quality improvement projects, and conducting thorough assessments of product and system designs. The engineer will validate critical design inputs, guide risk management activities, and leverage post-market data for continuous improvement. Additionally, this position requires ensuring audit readiness, managing CAPA processes, and building effective stakeholder relationships.

Requirements

Bachelor's / Master's Degree in Mechanical Engineering, Electronics Engineering, Science, or equivalent.
Minimum 5+ 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.

Nice To Haves

Six Sigma Green Belt
Design Quality Management
Data Analysis & 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
Product Test Design

Responsibilities

Creates and executes comprehensive process validation strategies using statistical tools to ensure the seamless transition of new products to production, meeting quality and regulatory standards, working under limited supervision.
Handles the entire design control process, from eliciting and validating design inputs to managing verification, validation, and smooth design transfer, ensuring rigorous adherence to regulatory and quality standards.
Keeps a check on the drafting and updating of detailed quality engineering documents, including quality plans for hardware, software, and systems, ensuring all documentation is accurate, up-to-date, and compliant with regulatory requirements.
Ensures the success of quality improvement projects by integrating quality, reliability, and Post Market Surveillance (PMS) insights into all stages of the product lifecycle, driving continuous enhancement of product quality and reliability.
Conducts thorough assessments of product and system designs, reviews performance data, and performs root cause analysis to identify and address quality deficiencies, ensuring the highest standards of design excellence.
Validates critical design inputs such as usability, reliability, performance, manufacturability, and safety, ensuring alignment with both quality standards and regulatory requirements.
Guides comprehensive risk management activities throughout the product lifecycle, ensuring potential risks are accurately identified, assessed, and effectively mitigated to uphold product safety and quality.
Leverages post-market performance data to assess product effectiveness in the field, providing actionable feedback to manufacturing and design teams, and initiating corrective actions when necessary.
Ensures preparation for quality audits and inspections, maintaining all necessary documentation and processes to demonstrate compliance with both internal and external quality standards.
Records, manages, and executes CAPA processes, including problem identification, root cause analysis, and the implementation of solutions to prevent recurrence and drive continuous improvement.
Applies continuous improvement techniques to enhance quality practices, ensuring ongoing audit readiness and strict adherence to both internal and external quality standards throughout the product lifecycle.
Builds effective relationships with internal and external stakeholders, providing guidance and mentorship to ensure alignment with quality standards and project milestones.