Supplier Quality Engineer (SQE) – Medical Devices
About the role
About the Role · We are seeking an experienced Supplier Quality Engineer to support a high-reliability, regulated medical-device manufacturing environment. · This is a hands-on role at the intersection of supplier quality, manufacturing operations and engineering, focused on resolving real component-quality issues, strengthening supplier performance and supporting robust component qualifications. Key Responsibilities · Partner with Manufacturing, Operations and Quality teams in material review activities to assess, triage and disposition component nonconformities. · Own supplier-quality investigations from initial issue review through containment, root-cause analysis, corrective action and evidence-based closure. · Manage Quality Notifications (QNs), Supplier Quality Notifications (SQNs) and Supplier Corrective Action Requests (SCARs), including containment, supplier communication, root-cause investigation, corrective action and effectiveness follow-up. · Use SAP or comparable ERP/QMS tools to document and progress nonconformities and quality actions. · Support new and changed component qualifications through APQP/PPAP and review of control plans, FMEAs and process-validation evidence. · Apply structured problem-solving methods, including 8D, 5 Why, FMEA and Root Cause Analysis, to determine whether defects originate from the supplier, manufacturing process or handling conditions. · Work directly with suppliers on complex quality issues and support onsite supplier investigations when required. · Monitor supplier performance and collaborate cross-functionally to reduce recurrence and maintain quality-system compliance. · Technical Experience We Value · Hands-on Supplier Quality or Manufacturing Quality experience in a regulated manufacturing environment; medical-device experience is strongly preferred. · Practical experience investigating PCB/PCBA and electrical/electronic component defects; exposure to plastic injection-molded components is an advantage. · Practical experience with MRB, nonconformance management, QN/SQN, SCAR, CAPA, supplier corrective actions, Root Cause Analysis, 8D and 5 Why. · Working knowledge of APQP, PPAP, FMEA, control plans, supplier audits and component/process qualification. · Understanding process validation concepts, including IQ/OQ/PQ, within a regulated quality system. · Ability to communicate technical findings clearly with suppliers, engineering, manufacturing and quality stakeholders. Qualifications · Bachelor’s degree in engineering or a related technical discipline. · 5+ years of relevant Supplier Quality, Manufacturing Quality or Quality Engineering experience; deeper experience is preferred for senior-level consideration. · Experience using SAP or a comparable ERP/QMS platform in quality workflows. · Strong analytical judgment, technical communication and supplier-facing problem-solving capability. · Preferred · Experience in FDA-regulated medical-device manufacturing; strong automotive supplier-quality experience may also be considered. · ASQ quality certification, Lean Six Sigma Green/Black Belt, or relevant quality/auditor credential is a plus. · Experience supporting supplier assessments, regulated audits or qualification activities is advantageous. What We Are Looking For · A proactive, technically grounded SQE who can step into a manufacturing environment, understand a defect beyond the paperwork, ask the right questions, work constructively with suppliers and drive issues to closure. · The strongest candidates will combine sound quality-system knowledge with practical component-level judgment and ownership. Work Expectations · Based in, or able to work onsite in, Bothell, Washington at least 3 days per week. · Willing and able to travel domestically approximately 25%, including supplier-site support when business needs require it. Available to begin the engagement on a near-term basis