Supplier Quality Engineer

Katalyst-Healthcares-; Bothell (WA); On-site; USD 95,000 - 150,000; Full time

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Supplier Quality

Root Cause Analysis

CAPA

8D

FMEA

PPAP

QC tools

Education

Bachelor's degree in engineering

Tools

SAP

Job description

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.