Product Design Quality Engineer: Design and Validation Lead

ELYON International; Bothell (WA); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Paid sick leave

Medical/Dental (optional)

401 (k) Retirement Plan (optional)

Employer Paid Life Insurance

Employer Paid Short Term Disability

Optional Life Insurance

Job summary

ELYON International, Inc. is seeking a senior Quality Engineer to lead process validation, design controls, and CAPA activities across hardware, software, and systems.

You will drive improvements, oversee risk management, and ensure regulatory and quality compliance throughout the product lifecycle. The role requires 5+ years of experience (or a Master's with less experience) in quality engineering or related fields, with Six Sigma Green Belt preferred.

Qualifications

• Bachelor's or Master's degree in engineering or science.
• 5+ years of experience in Quality Engineering, Safety Engineering, R&D Engineering, or equivalent — or, with a Master's degree, no experience required.
• Six Sigma Green Belt preferred.

Responsibilities

• Creates and executes comprehensive process validation strategies using statistical tools to ensure smooth transfer of new products to production.
• Manages design controls from inputs to verification/validation and design transfer, ensuring regulatory and quality compliance.
• Maintains and updates quality engineering documents for hardware, software, and systems.
• Drives quality improvement projects by integrating PMS insights into the product lifecycle.
• Performs design and product evaluations, reviews performance data, and conducts root-cause analysis to address deficiencies.
• Validates critical design inputs such as usability, reliability, performance, manufacturability, and safety.
• Leads risk management activities across the product lifecycle to mitigate hazards and ensure safety and quality.
• Uses post-market data to assess field performance and initiates corrective actions as needed.
• Prepares for quality audits and inspections with complete documentation and processes.
• Records and executes CAPA processes to prevent recurrence and drive improvement.
• Applies continuous improvement techniques to sustain audit readiness and compliance.
• Builds relationships with stakeholders and mentors teams to align with quality standards.

Skills

Design Quality Management

Data Analysis & Interpretation

Design for Quality

Root Cause Analysis

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

Education

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

Job description

ELYON International, Inc. is seeking a senior Quality Engineer to lead process validation, design controls, and CAPA activities across hardware, software, and systems.

You will drive improvements, oversee risk management, and ensure regulatory and quality compliance throughout the product lifecycle. The role requires 5+ years of experience (or a Master's with less experience) in quality engineering or related fields, with Six Sigma Green Belt preferred.