Senior Supplier Quality Engineer, Medical Devices

AMARIS GROUP SA; Bothell (WA); On-site; USD 110,000 - 140,000; Full time

Job summary

Amaris Consulting is seeking a skilled Supplier Quality Engineer to join its SQE team for a medical-device emergency care portfolio. You will manage supplier quality issues from rejection through corrective action, qualification, and effectiveness checks, in a regulated ISO 13485/FDA environment.

You will participate in MRB, lead defect investigations, manage NCRs/SCARs, and drive APQP/PPAP part qualification with suppliers. On-site Bothell, WA, with US work authorization required.

Qualifications

• 5+ years in Supplier Quality Engineering in medical devices or FDA-regulated sector.
• Knowledge of ISO 13485 and FDA 21 CFR 820.

Responsibilities

• Review supplier-related rejections and drive disposition.
• Lead MRB investigations and defect analyses.
• Process SAP QM defects, NCRs, and dispositions.
• Coordinate supplier quality notifications and CAPAs.
• Support IQ/OQ/PQ and APQP/PPAP activities.
• Engage with suppliers for corrective actions and quality improvements.
• Act as supplier-quality point of contact during FDA audits.

Skills

SAP QM

MRB involvement

8D problem solving

APQP/PPAP

ISO 13485 knowledge

FDA 21 CFR 820

Education

Bachelor's degree in engineering

Tools

SAP QM

Job description

Amaris Consulting is seeking a skilled Supplier Quality Engineer to join its SQE team for a medical-device emergency care portfolio. You will manage supplier quality issues from rejection through corrective action, qualification, and effectiveness checks, in a regulated ISO 13485/FDA environment.

You will participate in MRB, lead defect investigations, manage NCRs/SCARs, and drive APQP/PPAP part qualification with suppliers. On-site Bothell, WA, with US work authorization required.