Sr Director, Quality
Core
Develop, implement, and coordinate product assurance programs to prevent or eliminate defects in new or existing products for manufacturing and design locations across the Americas, Europe, and Asia.
Role type
Sr Director, Quality
Builds
Quality systems, compliance strategies, and regulatory frameworks for global manufacturing sites.
Domain
Manufacturing / Quality Assurance / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Quality system development, regulatory compliance (ISO 13485), coaching QA chiefs, strategic planning, cross-functional leadership, audit management, process improvement, stakeholder management, global regulatory landscape analysis
Preferred skills
Automotive industry experience, OEM relationship management, networking with industry bodies, new product development integration
Technologies
ISO 13485, statistical process control, quality management systems
Responsibilities
Develop and maintain quality systems for manufacturing and design locations; coach QA chiefs on compliance strategies; provide global regulatory advice; monitor external QA landscape; ensure compliance with ISO 13485 and other regulations; prepare for regulatory inspections; implement quality strategies across the organization; conduct inspections, audits, and statistical process control research; establish quality programs and controls; work with R&D on new product start-ups.
Seniority
Senior, strategic leadership & mentorship