Product Design Quality Engineer-Hybrid

Elyon International; Bothell (WA); On-site; USD 90,000 - 150,000; Full time

Benefits offered by this job

Paid sick leave

Medical/Dental (optional)

401(k) plan

Life insurance

Short-term disability

Optional life insurance

Job summary

ELYON International, Inc. is seeking an experienced Quality Engineer to lead design control, process validation, and CAPA activities across hardware, software, and systems, ensuring strict adherence to regulatory and quality standards while guiding teams under limited supervision.

The role focuses on risk management, post-market surveillance, data analysis, and continuous improvement, with responsibilities including audits, documentation, and cross‑functional mentorship to sustain top‑tier

Qualifications

• Lead design control and validation activities across hardware, software and systems.
• Perform risk assessments and CAPA to ensure regulatory compliance.
• Develop and maintain quality documentation and plans.

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.

Skills

Quality Engineering

Statistical analysis

Regulatory knowledge

Risk management

CAPA

Documentation

Six Sigma Green Belt

Continuous improvement

Education

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

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.