About the Role:
We are seeking an experienced Supplier Quality Engineer to support a highly reliable, 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.