Senior Supplier Quality Engineer - Audit & SCAR Lead

Kids for the Future; Madison (WI); On-site; USD 110,000 - 150,000; Full time

Job summary

NeuWave Medical is seeking a Lead Supplier Quality Engineer to own supplier quality management across the approved supplier base, driving qualifications, corrective actions, and audit programs to meet quality and regulatory requirements.

You will classify suppliers by risk, maintain ASL, lead supplier audits, and manage SCAR and SCN processes with cross-functional teams. Travel up to 25% may be required.

Qualifications

• Bachelor's degree in Engineering or related field.
• 5+ years quality engineering at a medical device maker, supplier quality focus.
• Working knowledge of ISO 13485 and 21 CFR 820.
• Proficient with Microsoft Office suite.

Responsibilities

• Assess and classify suppliers; maintain ASL and supplier files.
• Lead initial and periodic supplier qualifications; coordinate assessments.
• Lead supplier quality audits (on-site/remote) and issue reports.
• Lead SCAR process end-to-end; track CAPs to timelines; verify effectiveness.
• Oversee SCNs with cross-functional teams (R&D, Operations).
• Approve RMA dispositions and coordinate returns of nonconforming goods.
• Support internal/external audits, hosting regulatory and Notified Body auditors.

Skills

Supplier Quality

Audit Leadership

SCAR Process

CAP Tracking

Change Control

Regulatory Compliance

Education

Bachelor's degree in Engineering

Tools

ComplianceQuest

ERP Systems

Job description

NeuWave Medical is seeking a Lead Supplier Quality Engineer to own supplier quality management across the approved supplier base, driving qualifications, corrective actions, and audit programs to meet quality and regulatory requirements.

You will classify suppliers by risk, maintain ASL, lead supplier audits, and manage SCAR and SCN processes with cross-functional teams. Travel up to 25% may be required.