Director, Quality Assurance and Vigilance
Core
Senior quality leader for the Design Center responsible for leading the local Quality organization, owning the QMS, and ensuring product designs meet regulatory, compliance, safety, and performance requirements throughout their lifecycle.
Role type
Director, Quality Assurance and Vigilance (Design Center)
Builds
MedTech product designs and quality systems for the Design Center
Domain
Medical Technology (MedTech) / Regulatory Compliance
Required skills
Quality Management System (QMS) ownership, Design Controls, Risk Management (ISO 14971), Design Transfer, Supplier Quality Management, Audit/Inspection readiness, New Product Development (NPD) leadership, Post-Market Surveillance support, Cross-functional collaboration
Preferred skills
Experience with FDA QSR/QMSR, MDR, ISO 13485, IEC 62366, IEC 62304, DfX programs (DfM, DfA, DfS), Change Control, CAPA systems
Technologies
ISO 13485, ISO 14971, FDA 820.30, MDR, IEC 62366, IEC 62304
Responsibilities
Lead the site Quality organization and create vision/strategy aligned with Global Quality; Ensure effective implementation of Design Controls and Risk Management; Lead Design Transfer activities from R&D to manufacturing; Oversee Supplier Quality Management for design and manufacturing phases; Support Post-Market Surveillance and field performance investigations; Ensure site readiness for FDA inspections and Notified Body audits.
Seniority
Director, strategic leadership & organizational management