Product Design Quality Engineer-Hybrid

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

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.