Systems Design Quality Engineer

Elyon International; Bothell (WA); On-site; USD 110,000 - 140,000; 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 a quality-focused engineering leader seeking a candidate to drive design verification, validation, and transfer across hardware, software, and systems.

You will lead risk assessments, CAPA, and continuous improvement initiatives while ensuring regulatory and quality compliance throughout the product lifecycle. Responsibilities include drafting and maintaining quality plans, performing root-cause analysis, and guiding cross-functional teams through audits and

Qualifications

• Bachelor's or Master's degree in engineering or science as stated.
• Minimum 5+ years experience in Quality Engineering, Safety Engineering, R&D Engineering, or equivalent, or a Master's with no experience.
• Certification not required, but Six Sigma Green Belt preferred.

Responsibilities

• Create and execute process validation strategies using statistical tools.
• Lead design control, from inputs to verification, validation, and design transfer.
• Draft and maintain quality documents for hardware, software, and systems.
• Drive quality improvement through PMS insights and lifecycle integration.
• Perform design reviews, root cause analysis, and CAPA implementation.
• Validate usability, reliability, performance, manufacturability, and safety.
• Guide risk management across product lifecycle and ensure mitigation.
• Use post-market data to drive corrective actions with manufacturing/design teams.
• Prepare for quality audits and inspections with proper documentation.
• Record and manage CAPA processes and ongoing improvements.
• Apply continuous improvement techniques and maintain audit readiness.
• Engage with internal and external stakeholders to align with standards and milestones.

Skills

Data Analysis

Root Cause Analysis

CAPA

Design for Quality

Regulatory Requirements

Risk Assessment

Technical Documentation

Continuous Improvement

Product Quality and Reliability

Defect Management

Design Verification Planning

Design Validation Planning

Product Test Design

Six Sigma Green Belt

Education

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

Job description

Job 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.

Requirements

• Minimum required Education: Bachelor's / Master's Degree in Mechanical Engineering, Electronics Engineering, Science, or equivalent.
• Minimum required Experience: 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.
• Minimum required Certification: N/A

Preferred Qualifications & Skills

• Preferred Certification: Six Sigma Green Belt
• Preferred Skills:
  • 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

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

ELYON International, Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.