Sr Auditor QA
Core
Lead complex supplier and internal audits to ensure compliance with FDA regulations and ISO standards for a global portfolio of sterile products, APIs, medical devices, and pharmaceuticals.
Role type
Senior Quality Assurance Auditor (Regulatory Compliance)
Builds
Regulatory compliance for Medline's diverse finished product portfolio and contract sterilizers/laboratories
Domain
Medical device and pharmaceutical manufacturing
Deliverable
client delivery
Required skills
FDA regulations (21 CFR 820, 210/211), ISO 13485, process validation, method validation, sterilization processes, CAPA management, audit planning and execution, risk assessment
Preferred skills
USP 61/62 for Microbial Testing, novel and high-risk product compliance
Technologies
None stated
Responsibilities
Plan and execute complex supplier and internal audits; evaluate supplier approval status; write audit reports; coordinate travel for domestic and international audits; assist in FDA inspection preparation; manage CAPA follow-up; mentor junior auditors
Seniority
Senior, hands-on IC with team leadership