Supplier Quality & Audit Engineer

Supplier Quality & Audit Engineer

We're a small supplier quality team inside Promega's Quality Assurance and Regulatory Affairs organization, and the work is substantive: supplier audits, leading internal audits, and regulatory inspection support that keeps a global supplier network in regulated industries running. We've built AI-augmented tools into how we work, not as a novelty, but because it sharpens the judgment-intensive parts of the job. The team operates with a lot of autonomy;

we trust each other to own our domains and come with recommendations, not just problems. Promega is privately held and thinks in decades, which means we invest in people and tools without the pressure of quarterly cycles. If you want to do real quality work, develop toward regulatory inspection hosting, and be part of a team figuring out what modern quality practice actually looks like, this is a good place to be.

This role sits at the center of Promega's supplier quality and audit programs, and the work is hands-on from the start.

You'll lead supplier audits end-to-end: planning, on-site execution, findings, corrective action oversight. You'll serve as lead auditor within Promega's internal audit program at our Madison site, conducting audits with the credentialed independence the role requires, while overall program ownership and scheduling sit with another member of the quality organization. You'll support external regulatory inspections and customer audits, and over time develop toward hosting those interactions yourself alongside our current audit leads.

In between the cyclical audit work, you'll manage the day-to-day supplier quality operations that keep the program running: corrective action requests, supplier performance monitoring, change notifications, and approval workflows.

Your name goes on audit reports that may become regulatory evidence, and AI-augmented tools support the planning, data retrieval, and drafting behind that work, so more of your time goes toward the judgment calls only a credentialed professional on-site can make.

If you're looking for a role where you own something significant, build toward regulatory inspection hosting, and work with tools that reflect where the quality field is actually going, this is worth a close look.

The Supplier Quality & Audit Engineer leads supplier audits, serves as lead auditor for Promega's internal quality system audit program, and supports the facilitation of external regulatory inspections and customer audits across Promega. This role serves as Promega's front-line resource across supplier quality operations and all three audit domains, requiring direct on-site engagement with suppliers, manufacturing and laboratory personnel, and external regulatory bodies.

On-site physical presence, real-time process observation, and face-to-face interaction with auditees and inspectors are core requirements of this work. The individual maintains strong technical knowledge of applicable regulatory requirements (ISO 13485, FDA 21 CFR 820, IVDR, MDSAP) and applies this knowledge through hands-on audit execution. The role carries personal accountability for audit findings and supplier adequacy determinations that may serve as regulatory evidence, a judgment and sign-off responsibility that cannot be delegated to automated systems regardless of the AI-augmented tools supporting the work.

Core duties include:

• Serving as lead auditor for supplier audits: plans and executes audit scheduling, conducts on-site or remote audits, generates audit reports, oversees corrective and preventive action plans, verifies effectiveness, and reports results to management with executive authority.
• Conducting on-site supplier audits requiring direct observation of manufacturing processes, laboratory operations, material controls, and quality management system implementation as they operate in practice.
• Applying regulatory knowledge (ISO 13485, FDA 21 CFR 820, IVDR, MDSAP, ICH Q7) to identify systemic compliance risks and drive supplier improvement.
• Utilizing structured pre-audit preparation processes, including Promega's AI-augmented audit lifecycle tools, and data sources (SCAR history, NCRs, supplier performance data, previous audit findings, regulatory references) to develop tailored audit plans and question sets for each supplier audit.
• Rendering the independent professional determination of supplier process adequacy underlying each audit finding — judgment requiring on-site observation and direct engagement that AI-augmented planning and reporting tools support but do not replace.
• Serving as Promega Madison's dedicated, on-site internal auditor, providing the sustained and independent audit program ISO 13485 and MDSAP require without reliance on interim or cross-site coverage.
• Planning and leading internal quality system audits at Promega Madison and other applicable sites, including scheduling, on-site process walkthroughs, face-to-face interaction with department personnel, finding documentation, report…