Auditor QA
Core
Audit global supplier base and internal divisions against FDA regulations and ISO standards for Medline's diverse product portfolio including sterile products, APIs, medical devices, and pharmaceuticals.
Role type
Quality Assurance Auditor (Regulatory Compliance)
Builds
Regulatory compliance for Medline's finished product portfolio and contract sterilizers/laboratories
Domain
Medical device and pharmaceutical manufacturing
Deliverable
client delivery
Required skills
Supplier audit planning and execution, QMS evaluation, CAPA management, audit reporting, regulatory response drafting, travel coordination
Preferred skills
FDA regulations (21 CFR 820, 210/211) knowledge, ISO 13485 experience, process validation knowledge, sterilization process knowledge
Technologies
ISO 13485, MDSAP, MDD/MDR
Responsibilities
Plan and execute complex supplier audits, evaluate supplier approval status, manage quality initiatives and SOP revisions, conduct CAPA follow-up, write audit reports, assist in FDA inspection preparation
Seniority
Mid-level, hands-on IC