Senior Supplier Quality Engineer - Medical Devices

Amaris Consulting | Part of Mantu; Bothell (WA); On-site; USD 90,000 - 140,000; Full time

Job summary

Amaris Consulting is seeking a Supplier Quality Engineer to join an established SQE team supporting a medical-device emergency care portfolio. You’ll manage supplier-related quality issues from initial rejection through investigation, corrective action, qualification, and effectiveness checks, in an environment governed by ISO 13485 and FDA 21 CFR 820.

This on-site role in Bothell, WA requires MRB participation, SAP QM expertise, and collaboration with suppliers, manufacturing, and regulatory

Qualifications

• 5+ years of Supplier Quality Engineering experience in FDA-regulated sectors.
• Working knowledge of ISO 13485 and FDA 21 CFR 820.
• Hands-on SAP QM experience with notifications, defect processing, and disposition.
• Experience leading MRB meetings and defect investigations.
• Experience managing SQNs, SCARs and 8D activities.
• Experience with APQP and PPAP part qualification.
• Experience supporting IQ, OQ and PQ process validation.
• Experience with plastic injection molding, PCBA, PCB components.

Responsibilities

• Review supplier-related rejections and drive disposition.
• Attend MRB meetings and lead defect investigations.
• Process defect data and manage QN workflow in SAP QM.
• Keep dispositions on schedule and documented.
• Issue and manage Supplier Quality Notifications and SCARs.
• Track corrective actions, containment, and effectiveness.
• Lead component/process qualification activities using APQP/PPAP.
• Support supplier process validation (IQ/OQ/PQ).
• Collaborate with suppliers on corrective actions and quality improvements.
• Serve as supplier-quality point during FDA inspections and audits.

Skills

Supplier Quality Engineering

MRB experience

Regulatory knowledge

Quality systems thinking

Tools

SAP QM

APQP/PPAP

IQ/OQ/PQ

QNs/Dispositions

Job description

Amaris Consulting is seeking a Supplier Quality Engineer to join an established SQE team supporting a medical-device emergency care portfolio. You’ll manage supplier-related quality issues from initial rejection through investigation, corrective action, qualification, and effectiveness checks, in an environment governed by ISO 13485 and FDA 21 CFR 820.

This on-site role in Bothell, WA requires MRB participation, SAP QM expertise, and collaboration with suppliers, manufacturing, and regulatory