IS
Systems Design Quality Engineer
inSync Staffing Inc.
- 🇺🇸 United States
- Hybrid
- Mid level
- 1 day ago
- Risk Management
- CAPA
- Health insurance
1 day ago
Not enough detail in this posting to match
Hours: Monday–Friday; 8:00 AM–5:00 PM
Location: Bothell, WA 98021 – Hybrid
Overview Seeking an experienced Systems Design Quality Engineer to support product design quality, design controls, risk management, validation, and continuous improvement throughout the product lifecycle. This role works closely with engineering, manufacturing, quality, and other cross-functional teams to ensure products meet applicable quality and regulatory requirements from initial design through post-market performance. Important: Same position as JP4227. Do not cross-submit candidates.
Required Skills
- 5+ years of relevant experience with a Bachelor's degree in Quality Engineering, R&D Engineering, Safety Engineering, Design Quality, or a related field.
- Strong experience with design controls and Design Quality Management.
- Experience with design verification and validation (V&V) planning and execution.
- Knowledge of risk management and risk assessment throughout the product lifecycle.
- Experience with CAPA methodologies and root cause analysis (RCA).
- Experience developing and maintaining technical and quality documentation.
- Understanding of applicable regulatory and quality requirements.
- Experience evaluating product quality, reliability, performance, manufacturability, usability, and safety.
- Strong data analysis and interpretation skills.
- Ability to work cross-functionally with engineering, manufacturing, quality, and other stakeholders.
- Develop and execute process validation strategies using statistical tools to support new product introduction and production transfer.
- Manage design control activities, including design inputs, verification, validation, and design transfer.
- Develop and maintain quality plans and engineering documentation for hardware, software, and systems.
- Incorporate quality, reliability, and Post-Market Surveillance (PMS) findings throughout the product lifecycle.
- Review product and system designs and analyze performance data to identify quality deficiencies.
- Conduct root cause investigations and implement corrective actions.
- Validate critical design inputs related to usability, reliability, performance, manufacturability, and safety.
- Lead and support product risk-management activities and mitigation strategies.
- Analyze post-market performance and provide actionable feedback to design and manufacturing teams.
- Support quality audits and inspections and maintain audit-ready documentation.
- Manage and execute CAPA activities, including problem identification, root cause analysis, corrective actions, and prevention of recurrence.
- Apply continuous-improvement methodologies to improve product quality and reliability.
- Partner with internal and external stakeholders to maintain quality standards and meet project milestones.
- Design for Quality (DFQ).
- Product quality and reliability.
- Defect management.
- Product test design.
- Privacy, safety, and security considerations.
- Statistical analysis and process validation.
- Six Sigma Green Belt certification.
- Bachelor's or Master's degree in Mechanical Engineering, Electronics Engineering, Science, or an equivalent technical discipline.
- Bachelor's degree candidates require 5+ years of relevant experience.
- Master's degree candidates may be considered without prior experience based on the stated requirements.
​Benefits (employee contribution):
Health insurance
Health savings account
Dental Insurance
Vision Insurance
Flexible spending accounts
Life insurance
Systems Design Quality Engineer · inSync Staffing Inc.