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:

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

Key skills

About this role