Lead Supplier Quality & Audit Engineer

Promega Corporation; Madison (WI); On-site; USD 95,000 - 130,000; Full time

Job summary

Promega Corporation in Madison seeks a Supplier Quality & Audit Engineer who leads supplier audits, serves as lead auditor for internal quality systems, and supports external regulatory inspections with technical depth.

The role requires on‑site engagement with suppliers, manufacturing, and labs, with ISO 13485, FDA 21 CFR 820, and MDSAP knowledge. Travel domestically and internationally is involved as needed.

Qualifications

• Minimum BS/BA in science, engineering, or technical field.
• ASQ CQA or equivalent certification preferred.
• 5+ years in QA, QC, regulatory, or manufacturing environments.

Responsibilities

• Lead supplier audits end‑to‑end: planning, on‑site or remote audits, reporting, CAPA oversight.
• Lead internal audits for ISO 13485, MDSAP, and related programs.
• Support external regulatory inspections and customer audits as needed.
• Maintain internal audit schedules and records; ensure regulatory readiness.
• Utilize AI‑augmented tools for audit planning, data retrieval, and reporting.

Skills

Lead Auditor

Auditing

Quality Assurance

Regulatory compliance

Data analysis

ISO 13485

FDA 21 CFR 820

AI-assisted auditing tools

Education

BS/BA in science, engineering, or technical field

ASQ Certified Quality Auditor (CQA)

Tools

SAP

Power BI

Excel

EtQ

MasterControl

Job description

Promega Corporation in Madison seeks a Supplier Quality & Audit Engineer who leads supplier audits, serves as lead auditor for internal quality systems, and supports external regulatory inspections with technical depth.

The role requires on‑site engagement with suppliers, manufacturing, and labs, with ISO 13485, FDA 21 CFR 820, and MDSAP knowledge. Travel domestically and internationally is involved as needed.