Onsite Senior Supplier Quality Engineer – Medical Devices

Katalyst-Healthcares-; Bothell (WA); Presencial; USD 95.000 - 150.000; Jornada completa

Descripción de la vacante

Katalyst-Healthcares- is seeking an experienced Supplier Quality Engineer to support a regulated medical-device manufacturing environment in Bothell, WA. This hands-on role combines supplier quality, manufacturing, and engineering to resolve component-quality issues and strengthen supplier performance.

The ideal candidate has 5+ years in supplier or quality engineering, hands-on experience with PCB/electronics defects, and proficiency in APQP/PPAP, FMEA and CAPA processes.

Formación

• Bachelor's degree in engineering is required.
• 5+ years in supplier quality, manufacturing quality or quality engineering in regulated environments.
• Experience using SAP or similar ERP/QMS for quality workflows.
• Strong analytic judgment and technical communication with suppliers.

Responsabilidades

• Partner with Manufacturing, Operations and Quality to triage and disposition component nonconformities.
• Lead supplier-quality investigations from issue review to containment, root cause, corrective action and validation.
• Manage QNs, SQNs, and SCARs including containment and effectiveness follow-up.
• Document nonconformities and actions in SAP or equivalent ERP/QMS systems.
• Support APQP/PPAP through control plans, FMEAs and process validation evidence.
• Apply 8D, 5 Why and RCA methods to determine origin of defects.
• Coordinate with suppliers on complex quality issues and onsite investigations when needed.
• Monitor supplier performance and drive crossfunctional improvements to sustain quality.

Conocimientos

Supplier Quality

Root Cause Analysis

CAPA

8D

FMEA

PPAP

QC tools

Educación

Bachelor's degree in engineering

Herramientas

SAP

Descripción del empleo

Katalyst-Healthcares- is seeking an experienced Supplier Quality Engineer to support a regulated medical-device manufacturing environment in Bothell, WA. This hands-on role combines supplier quality, manufacturing, and engineering to resolve component-quality issues and strengthen supplier performance.

The ideal candidate has 5+ years in supplier or quality engineering, hands-on experience with PCB/electronics defects, and proficiency in APQP/PPAP, FMEA and CAPA processes.