Supplier Quality Engineer

S-Solutions Inc- a SyeDyn Company; Bothell (WA); On-site; USD 110,000 - 140,000; Full time

Job summary

S-Solutions Inc- a SyeDyn Company in Bothell, WA is seeking an experienced Supplier Quality Engineer to support a high-reliability, regulated medical-device manufacturing environment. This hands-on role partners with manufacturing, operations and quality teams to resolve component quality issues, strengthen supplier performance and drive APQP/PPAP activities.

The ideal candidate has 5+ years in supplier or manufacturing quality, hands-on experience with SQNs/SCARs, SAP or ERP/QMS, and strong

Qualifications

• Bachelor’s degree in engineering or related technical discipline.
• 5+ years of relevant Supplier Quality, Manufacturing Quality or Quality Engineering experience.
• Experience using SAP or a comparable ERP/QMS platform in quality workflows.
• Strong analytical judgment, technical communication and supplier-facing problem-solving capability.

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.

Skills

Quality engineering

Regulated manufacturing

Root cause analysis

8D problem solving

FMEA

APQP/PPAP

Education

Bachelor's degree in engineering

Tools

SAP

ERP/QMS platforms

Job description

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.

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.

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.