Product Design Quality Engineer

ELYON International

. Create and execute comprehensive process validation strategies using statistical tools for new-product transition to production .

Posted 9/22/2026contractBothell • Washington • United StatesMid-LevelSenior💰 $55 per hourWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in process validation strategies, design control management, and quality engineering documentation. Proficient in data analysis, risk assessment, and continuous improvement methodologies to ensure product quality and compliance.

Highest-signal resume keywords

Process Validation StrategiesDesign Control ManagementRoot Cause AnalysisSix Sigma Green BeltCAPA Methodologies

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Data Analysis & InterpretationDesign for QualityDesign Verification PlanningDesign Validation PlanningProduct Test Design

Soft Skills

Stakeholder Relationship ManagementMentorship

Tools & Technologies

Quality Engineering DocumentsQuality Plans

Certifications & Qualifications

Six Sigma Green Belt

Industry Keywords

Regulatory RequirementsRisk AssessmentContinuous ImprovementProduct Quality and ReliabilityDefect Management

About the role

Key responsibilities & impact

Create and execute comprehensive process validation strategies using statistical tools for new-product transition to production
Manage the complete design control process, including design inputs, verification, validation, and design transfer
Draft and update quality engineering documents and quality plans for hardware, software, and systems
Integrate quality, reliability, and Post Market Surveillance insights throughout the product lifecycle
Assess product and system designs, review performance data, and perform root cause analysis
Validate design inputs including usability, reliability, performance, manufacturability, and safety
Guide product-lifecycle risk management activities
Analyze post-market performance data and initiate corrective actions when necessary
Prepare for quality audits and inspections and maintain compliance documentation
Record, manage, and execute CAPA processes
Apply continuous improvement techniques and maintain audit readiness
Build stakeholder relationships and provide guidance and mentorship

Requirements

What you’ll need

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
Preferred Certification: 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

Benefits

Comp & perks

Paid sick leave
Medical/Dental (optional)
401 (k) Retirement Plan (optional)
Employer Paid Life Insurance
Employer Paid Short Term Disability
Optional Life Insurance