Supplier Quality & Audit Engineer

Promega•Madison, WI

30d•Onsite

About The Position

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 own Promega's internal audit program at our Madison site, serving as the credentialed auditor of record with the independence that requires. 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.

Requirements

Minimum BS/BA in science, engineering, or technical field.
Minimum 5 years’ experience in a QA, QC, regulatory, or manufacturing environment.
Minimum 3 years of demonstrated lead auditor experience conducting supplier and/or internal audits to ISO 13485, FDA regulations, or other applicable requirements.
Experience conducting on-site audits requiring physical presence, process observation, and face-to-face engagement with auditees.
Working knowledge of ISO 13485, FDA 21 CFR 820, and/or other medical device quality system regulations.
Ability to work independently with minimal supervision and manage multiple audit program responsibilities simultaneously.
Excellent written, verbal, and presentation skills, including the ability to communicate findings clearly to internal stakeholders and external regulatory parties.
ASQ Certified Quality Auditor (CQA) or equivalent external quality auditor certification.
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.
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.

Nice To Haves

7 or more years’ experience in a QA, QC, or regulatory environment.
5 or more years of lead auditor experience across supplier, internal, and/or external audit domains.
Experience supporting or participating in external regulatory inspections (FDA, BSI, MDSAP) or customer audits.
Familiarity with IVDR, MDSAP, ICH Q7, or cGMP requirements.
Proficiency with SAP and electronic quality management systems (e.g., EtQ, MasterControl).
Experience with data analysis tools (e.g., Power BI, Excel) for supplier performance monitoring and quality metrics.
Medical device and/or life sciences industry experience.
Demonstrated ability to identify systemic issues, risks, or process gaps that a standard audit checklist would not surface on its own.

Responsibilities

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.
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.
Applies regulatory knowledge (ISO 13485, FDA 21 CFR 820, IVDR, MDSAP, ICH Q7) to identify systemic compliance risks and drive supplier improvement.
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.
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.
Initiates and tracks supplier audits to completion within the electronic quality management system.
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.
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.
Conducts process-based internal audits that require physical presence — observing operations as they actually occur, consistent with ISO 13485 and MDSAP internal audit requirements.
Maintains the internal audit schedule and program records to demonstrate ongoing compliance with regulatory requirements.
Operates as an independent auditor relative to the areas being audited, consistent with regulatory program requirements.
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.
Assists the External Audit Program Lead and site leadership in preparing department personnel and documentation in advance of scheduled regulatory inspections.
Engages inspectors with direct knowledge of site operations, processes, and quality systems as an experienced quality professional resource during live audits.
Creates and maintains procedures, forms, metrics, and electronic systems supporting the external audit program.
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.
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.
Monitors supplier performance through scorecard maintenance, trend analysis, and development of supplier evaluation and audit schedules.
Facilitates cross-functional supplier change notification assessments, including regulatory impact review and implementation action tracking.
Supports the supplier and material approval process, including ERP system maintenance and incoming inspection activities as needed.
Creates and maintains audit-related procedures, forms, and quality management system records needed to demonstrate regulatory compliance.
May contribute to management review and quality data review metrics generation.
Reviews supplier and quality agreements as needed and supports continuous improvement initiatives impacting the supplier quality and audit programs.
Demonstrates inclusion through their own words and actions and is accountable for a safe workspace. Acts with kindness, curiosity and respect for others.
Embracing and being open to incorporating Promega’s 6 Emotional & Social Intelligence (ESI) core principles in daily work.
Understands and complies with ethical, legal and regulatory requirements applicable to our business.