Job Description:
OUR TEAM: 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.
YOUR ROLE: 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.
JOB OBJECTIVE: 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:
Supplier Auditing
1. Serves 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.
2. Conducts on-site supplier audits requiring direct observation of manufacturing processes, laboratory operations, material controls, and quality management system implementation as they operate in practice.
3. Applies regulatory knowledge (ISO 13485, FDA 21 CFR 820, IVDR, MDSAP, ICH Q7) to identify systemic compliance risks and drive supplier improvement.
4. Utilizes 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.
5. Renders 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.
6. Initiates and tracks supplier audits to completion within the electronic quality management system.
Internal Auditing
7. Serves 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.
8. Plans and leads 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 issuance, and CAPA oversight.
9. Conducts process-based internal audits that require physical presence — observing operations as they actually occur, consistent with ISO 13485 and MDSAP internal audit requirements.
10. Maintains the internal audit schedule and program records to demonstrate ongoing compliance with regulatory requirements.
11. Operates as an independent auditor relative to the areas being audited, consistent with regulatory program requirements.
External Audit & Regulatory Inspection Support
12. Provides front-room support during external regulatory inspections (FDA, BSI, MDSAP) and customer audits — accompanying inspectors through manufacturing areas and laboratories, retrieving evidence in real time, and providing technical depth that supports audit hosts.
13. Assists the External Audit Program Lead and site leadership in preparing department personnel and documentation in advance of scheduled regulatory inspections.
14. Engages inspectors with direct knowledge of site operations, processes, and quality systems as an experienced quality professional resource during live audits.
15. Creates and maintains procedures, forms, metrics, and electronic systems supporting the external audit program.
16. Develops toward external audit and regulatory inspection hosting responsibilities over time by deepening regulatory interpretation skills, building credibility with inspectors and regulatory bodies, and learning hosting dynamics alongside Promega’s current audit hosts — expanding the organization’s inspection-hosting bench strength.
Supplier Quality Operations
17. Initiates and tracks Supplier Corrective Action Requests (SCARs) to completion, ensuring complete and effective root cause analysis and corrective action implementation in partnership with suppliers and internal stakeholders.
18. Monitors supplier performance through scorecard maintenance, trend analysis, and development of supplier evaluation and audit schedules.
19. Facilitates cross-functional supplier change notification assessments, including regulatory impact review and implementation action tracking.
20. Supports the supplier and material approval process, including ERP system maintenance and incoming inspection activities as needed.
Quality Program Support & Continuous Improvement
21. Creates and maintains audit-related procedures, forms, and quality management system records needed to demonstrate regulatory compliance.
22. May contribute to management review and quality data review metrics generation.
23. Reviews supplier and quality agreements as needed and supports continuous improvement initiatives impacting the supplier quality and audit programs.
24. Demonstrates inclusion through their own words and actions and is accountable for a safe workspace. Acts with kindness, curiosity and respect for others.
25. Embracing and being open to incorporating Promega’s 6 Emotional & Social Intelligence (ESI) core principles in daily work.
26. Understands and complies with ethical, legal and regulatory requirements applicable to our business.
KEY QUALIFICATIONS:
1. Minimum BS/BA in science, engineering, or technical field.
2. Minimum 5 years’ experience in a QA, QC, regulatory, or manufacturing environment.
3. Minimum 3 years of demonstrated lead auditor experience conducting supplier and/or internal audits to ISO 13485, FDA regulations, or other applicable requirements.
4. Experience conducting on-site audits requiring physical presence, process observation, and face-to-face engagement with auditees.
5. Working knowledge of ISO 13485, FDA 21 CFR 820, and/or other medical device quality system regulations.
6. Ability to work independently with minimal supervision and manage multiple audit program responsibilities simultaneously.
7. Excellent written, verbal, and presentation skills, including the ability to communicate findings clearly to internal stakeholders and external regulatory parties.
8. ASQ Certified Quality Auditor (CQA) or equivalent external quality auditor certification.
9. Demonstrated ability to exercise independent professional judgment in ambiguous or incomplete-information situations and to take personal accountability for audit findings and adequacy determinations, including those that may be used as evidence in regulatory proceedings.
10. Demonstrated proficiency in digital tools and technology, including Microsoft applications and mobile platforms, with the ability to adapt and leverage emerging technologies, such as artificial intelligence, to improve efficiency, automation, and collaboration. This includes daily, comfortable use of Promega’s AI-augmented audit planning, data retrieval, and report-drafting tools as part of standard workflow.
PREFERRED QUALIFICATIONS:
1. 7 or more years’ experience in a QA, QC, or regulatory environment.
2. 5 or more years of lead auditor experience across supplier, internal, and/or external audit domains.
3. Experience supporting or participating in external regulatory inspections (FDA, BSI, MDSAP) or customer audits.
4. Familiarity with IVDR, MDSAP, ICH Q7, or cGMP requirements.
5. Proficiency with SAP and electronic quality management systems (e.g., EtQ, MasterControl).
6. Experience with data analysis tools (e.g., Power BI, Excel) for supplier performance monitoring and quality metrics.
7. Medical device and/or life sciences industry experience.
8. Demonstrated ability to identify systemic issues, risks, or process gaps that a standard audit checklist would not surface on its own.
PHYSICAL DEMANDS:
1. Ability to travel domestically and internationally for supplier audits and regulatory inspections, as required.
2. Ability to remain stationary for several hours at a time.
3. Ability to move objects up to 30 pounds.
4. Ability to use a computer/Microsoft Office applications.
At Promega, we value diversity and strive to create an inclusive workplace. We are proud to be an Equal Opportunity Employer, making employment decisions without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability, or any other protected class.
