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 management systems for the Design Center
Domain
Medical Technology (MedTech) / Regulatory Compliance / Quality Management Systems
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Quality Management System (QMS) ownership, Design Controls (FDA 820.30/ISO 13485), Risk Management (ISO 14971), Design Transfer, Supplier Quality Management, CAPA governance, Audit/Inspection readiness, Cross-functional leadership
Preferred skills
Experience with MDR/FDA QSR/QMSR, Usability Engineering (IEC 62366), Software lifecycle (IEC 62304), DfX programs, Post-Market Surveillance support
Technologies
ISO 13485, ISO 14971, FDA 820.30, MDR, IEC 62366, IEC 62304, CAPA systems, QMS software
Responsibilities
Lead the site Quality organization and define QMS strategy; Ensure effective implementation of Design Controls and Risk Management; Lead Design Transfer activities from R&D to manufacturing; Govern the full CAPA process and drive continuous improvement; Prepare for and lead FDA inspections and Notified Body audits; Provide technical quality leadership for post-market performance and field investigations.
Seniority
Director, strategic leadership & organizational management
