IS
Product Design Quality Engineer
inSync Staffing Inc.
- 🇺🇸 United States
- On-site
- Mid level
- 2 days ago
- Risk Management
- CAPA
- Regulatory Compliance
- Health insurance
- Pension
2 days ago
Hours: Monday–Friday; 8:00 AM–5:00 PM
Location: Bothell, WA 98021 – Hybrid
Overview Seeking an experienced Product Design Quality Engineer to support design quality throughout the product lifecycle, from new product development and design controls through production transfer and post-market activities. This position focuses heavily on design controls, verification and validation (V&V), risk management, CAPA, root cause analysis, process validation, and regulatory compliance.
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 discipline.
- Strong experience with design controls and Design Quality Management.
- Hands-on experience with design verification and validation (V&V).
- Experience with risk management and risk assessment throughout the product lifecycle.
- Strong knowledge of CAPA and root cause analysis (RCA) methodologies.
- Experience with process validation and statistical analysis.
- Knowledge of applicable quality and regulatory requirements.
- Experience developing and maintaining quality plans and technical documentation.
- Ability to evaluate product reliability, performance, manufacturability, usability, and safety.
- Strong data analysis and interpretation skills.
- Ability to work effectively with engineering, manufacturing, quality, and other cross-functional teams.
- Develop and execute process validation strategies using statistical tools to support new product introduction and production transfer.
- Manage design control activities from design inputs through verification, validation, and design transfer.
- Develop and maintain quality engineering documentation and quality plans for hardware, software, and systems.
- Integrate 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 and preventive actions.
- Validate critical design inputs related to usability, reliability, performance, manufacturability, and safety.
- Lead and support product risk-management activities, including identification, assessment, and mitigation of potential risks.
- Analyze post-market performance and provide feedback to manufacturing and design teams.
- Manage and execute CAPA processes, including problem identification, RCA, corrective actions, and prevention of recurrence.
- Support quality audits and inspections and maintain audit-ready documentation.
- Apply continuous-improvement methodologies to enhance product quality and reliability.
- Partner with internal and external stakeholders to maintain quality standards and achieve project milestones.
- Design for Quality (DFQ).
- Design verification and validation planning.
- Product quality and reliability.
- Defect management.
- Product test design.
- Privacy, safety, and security requirements.
- 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.
Health insurance
Health savings account
Dental Insurance
Vision Insurance
Flexible spending accounts
Life insurance
Retirement plan
All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Product Design Quality Engineer · inSync Staffing Inc.