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Supplier Quality Engineer (SQE) Medical Devices & Electronics | Contract | Bothell, WA(Hybrid)

Anagha Techno SoftBothell, WA🇺🇸United States

Quick overview

SeniorityMid Senior
Work modeOn Site
LocationBothell, WA, United States

Job description

Supplier Quality Engineer (SQE) Medical Devices & Electronics | Contract | Bothell, WA
Supplier Quality Engineer (SQE) Medical Devices & Electronics
Location: Bothell, WA
Work Arrangement: Hybrid / Onsite Minimum 3 Days per Week
Experience: 5+ Years
Travel: Approximately 25% Domestic Travel
Job Overview
We are seeking an experienced Supplier Quality Engineer (SQE) to support a high-reliability, regulated manufacturing environment. The ideal candidate will have hands-on experience investigating supplier-related component defects, managing nonconformances, driving root-cause analysis, and implementing effective corrective actions.
Medical-device manufacturing experience is strongly preferred. Candidates with relevant electronics manufacturing or automotive supplier-quality experience may also be considered.
Key Responsibilities
  • Partner with Manufacturing, Operations, Engineering, and Quality teams to assess, investigate, and disposition component nonconformities.
  • Lead supplier-quality investigations from initial issue identification through containment, root-cause analysis, corrective action, and verified closure.
  • Manage Quality Notifications (QNs), Supplier Quality Notifications (SQNs), Supplier Corrective Action Requests (SCARs), and related CAPA activities.
  • Coordinate supplier communications, corrective-action plans, effectiveness checks, and documentation.
  • Utilize SAP or comparable ERP/QMS platforms to document quality issues and track corrective actions.
  • Support new and modified component qualifications using APQP, PPAP, FMEA, control plans, and process-validation evidence.
  • Apply structured problem-solving methodologies, including 8D, 5 Why, FMEA, and Root Cause Analysis.
  • Investigate PCB/PCBA, electrical/electronic component defects, and other manufacturing-related quality issues.
  • Collaborate with suppliers to identify process weaknesses, prevent recurrence, and improve supplier performance.
  • Participate in supplier audits, assessments, qualification activities, and onsite supplier investigations as required.
  • Support compliance with applicable quality-system and regulatory requirements.
Required Qualifications
  • Bachelor's degree in Engineering or a related technical discipline.
  • 5+ years of experience in Supplier Quality Engineering, Manufacturing Quality, or Quality Engineering.
  • Hands-on experience with supplier corrective actions, SCAR, CAPA, nonconformance management, MRB, and root-cause investigations.
  • Practical knowledge of 8D, 5 Why, FMEA, and structured problem-solving techniques.
  • Experience investigating component defects, preferably involving PCB/PCBA and electrical/electronic components.
  • Working knowledge of APQP, PPAP, control plans, supplier audits, and component/process qualification.
  • Experience using SAP or a comparable ERP/QMS platform.
  • Understanding of process-validation concepts, including IQ/OQ/PQ.
  • Strong analytical, documentation, communication, and supplier-management skills.
Preferred Qualifications
  • Experience in FDA-regulated medical-device manufacturing.
  • Knowledge of ISO 13485, ISO 9001, or other relevant quality-management standards.
  • Experience with plastic injection-molded components and electronics manufacturing.
  • Automotive supplier-quality experience, including APQP, PPAP, and IATF 16949.
  • ASQ certification, Lean Six Sigma Green Belt/Black Belt, or relevant quality-auditor credentials.
Work Expectations
  • Ability to work onsite in Bothell, Washington, at least three days per week.
  • Willingness to travel domestically approximately 25%, including supplier-site visits.
  • Availability to start in the near term.
Ideal Candidate
We are looking for a hands-on Supplier Quality Engineer who can investigate technical defects beyond documentation, collaborate effectively with suppliers and internal engineering teams, and drive corrective actions through successful closure. Candidates with strong component-level troubleshooting skills and regulated-manufacturing experience will be preferred.
Kindly provide the following basic details along with your updated resume:

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