Pay: $57.85 $58.85/hour 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.
Job Description
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.
Preferred Skills
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.
Education Requirements
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
Numbers & Facts
Location
Bothell, WA
Industry
Staffing/Employment Agencies
Company Size
50 to 99 employees
Year Founded
2014
Website
http://www.insyncstaffing.com/default.html
About Company
We recognize the VMS program management team is our customer and needs to be serviced with integrity, so we built and continue to improve upon our delivery methods as we strive to provide the highest quality service possible.
inSync Staffing’s management team recognized ten years ago the inevitable changes to the staffing industry being brought about by technology and the growing trend of Fortune 1000 corporations to outsource management of their contingent workforces to meet compliance and cost control goals. Rather than swim upstream against the changes, inSync Staffing has embraced MSP and VMS programs as our customers, not competitors. We asked program managers how they want to be serviced.
The result of their input is that we have structured inSync Staffing as a recruiting and customer service organization, unlike traditional staffing companies who sell directly to the end client. Our delivery model allows us concentrates our resources on how to best supply candidates in a very competitive MSP/VMS program environment.
Skills
Bug Tracking/Defect Managementunmatched
Continuous Improvementunmatched
Corrective Actionunmatched
Corrective and Preventative Action (CAPA) Systemsunmatched
Cross-Functionalunmatched
Data Analysisunmatched
Design Verificationunmatched
Documentationunmatched
Documentation Planunmatched
Electronic Engineeringunmatched
Employee Benefitsunmatched
Identify Issuesunmatched
Manufacturingunmatched
Market Analysisunmatched
Mechanical Engineeringunmatched
Performance Analysisunmatched
Process Developmentunmatched
Process Validationunmatched
Product Designunmatched
Product Lifecycleunmatched
Product Reviewsunmatched
Product Supportunmatched
Product Testingunmatched
Product/Service Launchunmatched
Quality Engineeringunmatched
Quality Managementunmatched
Quality Metricsunmatched
Regulationsunmatched
Regulatory Requirementsunmatched
Research & Development (R&D)unmatched
Risk Analysisunmatched
Risk Managementunmatched
Root Cause Analysisunmatched
Safety Engineeringunmatched
Statisticsunmatched
Surveillanceunmatched
Systems Analysisunmatched
Technical Writingunmatched
Technical/Engineering Designunmatched
Test Designunmatched
Usability Engineeringunmatched
Validation Testingunmatched
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