Supplier Quality Engineer

Katalyst Pro; Bothell (WA); Presencial; USD 85.000 - 125.000; Jornada completa

Descripción de la vacante

Katalyst Pro seeks an experienced Supplier Quality Engineer to support a high-reliability medical-device manufacturing environment. This hands-on role blends supplier quality, manufacturing operations and engineering to resolve component-quality issues, strengthen supplier performance and support robust qualifications.

You will partner with manufacturing, operations and quality teams, own supplier-quality investigations from containment to root cause, manage QNs/SQNs/SCARs, and document actions

Formación

• Bachelor's degree in engineering or related technical discipline.
• 5+ years of supplier quality, manufacturing quality, or quality engineering experience.
• Experience with SAP or comparable ERP/QMS platform in quality workflows.

Responsabilidades

• Partner with Manufacturing, Operations and Quality to triage and disposition component nonconformities.
• Own supplier-quality investigations from issue review through containment, root-cause, corrective action and closure.
• Manage QNs, SQNs and SCARs, including containment, supplier communication, root-cause investigation and effectiveness follow-up.
• Document nonconformities and quality actions in SAP or ERP/QMS.
• Support component qualifications via APQP/PPAP and review control plans, FMEAs and process-validation evidence.
• Apply 8D, 5 Why, FMEA and Root Cause Analysis to determine defect origin.
• Work with suppliers on complex quality issues and onsite investigations when required.
• Monitor supplier performance and collaborate to reduce recurrence and ensure compliance.

Conocimientos

Quality problem-solving

Root cause analysis

Supplier collaboration

Technical communication

Educación

Bachelor's degree in engineering or related technical discipline

Herramientas

SAP

Descripción del empleo

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.