Global medical device 기업

Quality Management Lead: Core Responsibilities Compliance & QMS: Manage the ISO/MDSAP/FDA-compliant QMS and serve as the ISO Management Representative. Audit & Inspection: Lead all internal/external audits (FDA, MDR) and manage corrective actions. System Oversight: Direct CAPA, Management Reviews, and Supplier Quality monitoring. Product Development: Oversee Design Controls, Risk Management (FMEA), and V&V (Product, Process, Software). Operational Leadership: Manage QA/QE/QC teams and drive continuous improvement (Lean/Six Sigma). Strategy & Culture: Report quality metrics to global leadership and mentor teams on compliance best practices.

Experience: 15+ years in FDA-regulated Quality/Regulatory roles, including 5+ years in senior leadership. Core Expertise: Strong background in Quality Engineering/Assurance with a focus on Design Controls and Risk Management. Regulatory Knowledge: Expert in FDA 21 CFR 820, ISO 13485, MDR, and MDSAP; proficient in ISO 14971, IEC 60601, and EN 62304. Technical Proficiency: Skilled in V&V, Root Cause Analysis, Statistical Methods (DOE), and Reliability Engineering. Audit & Metrics: Proven track record in managing regulatory audits (FDA/Notified Body) and developing quality dashboards. Leadership: Demonstrated ability to lead cross-functional teams, manage complex projects, and deliver technical presentations. Certification: Lean Six Sigma certification or equivalent experience preferred.

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