Medical Device Supplier Quality Engineer - Hands-On Impact

Katalyst Pro; Bothell (WA); On-site; USD 85,000 - 125,000; Full time

Job summary

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

Qualifications

• 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.

Responsibilities

• 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.

Skills

Quality problem-solving

Root cause analysis

Supplier collaboration

Technical communication

Education

Bachelor's degree in engineering or related technical discipline

Tools

SAP

Job description

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