Senior Associate II, Quality Audits
Core
Conduct risk-based internal and supplier audits to ensure compliance with ISO 13485 and GxP regulatory frameworks (FDA, EMA) for the Regional Americas.
Role type
Senior Associate II, Quality Audits
Builds
Inspection-ready audit reports and CAPA tracking for supplier qualification and site compliance
Domain
Medical device / Pharmaceutical / Regulatory Quality
Required skills
Risk-based auditing, ISO 13485, GxP (FDA/EMA), Supplier qualification, CAPA management, Audit planning, Stakeholder engagement, Regulatory compliance, Report writing, Concurrent audit management
Preferred skills
Advanced degree, ASQ Certification
Technologies
ISO 13485, GxP, FDA, EMA
Responsibilities
Plan and execute internal audits of sites; Plan and execute risk-based audits for external suppliers; Document and evaluate audit observations; Manage concurrent audits; Support tracking and review of audit responses and CAPAs; Engage with site and affiliate Quality and Operations teams; Interface with supplier Quality and technical teams; Contribute to inspection readiness activities
Seniority
Senior Associate II, hands-on IC