Skills
About the Role
We’re seeking a Quality Assurance Audit Manager to lead quality and compliance efforts for sterilization/micro-related products and processes. This role is based within commuting distance of our corporate headquarters in Northfield, IL, with potential relocation assistance for the right candidate. You’ll travel up to 40% for business purposes, supporting internal and supplier audit activities across regions.
Responsibilities
- Ensure quality and regulatory compliance across applicable requirements (including QSR, GMP, and ISO) for the product lifecycle and distribution regions.
- Lead internal and supplier audits for Medline, ensuring internal procedures and FDA/ISO expectations are met for medical device and drug products.
- Audit a broad, global supplier base against FDA regulations and ISO standards.
- Adapt departmental plans and priorities to respond to resource and operational challenges across assigned areas.
Requirements
- Experience managing quality and compliance activities in regulated environments (e.g., medical devices and/or pharmaceuticals).
- Knowledge of FDA requirements and ISO standards relevant to product quality and auditing.
- Proven audit leadership experience, including internal and supplier audits.
- Ability to travel up to 40% for business needs.
Benefits
- Relocation assistance may be available for the right candidate.
- Opportunity to drive enterprise-wide quality and compliance improvements.
- Travel required to support audits across domestic and international suppliers.