Sr. Quality Director
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. Quality Director (Quality Assurance & Regulatory Compliance)
Builds
Global quality systems, compliance strategies, and regulatory readiness for manufacturing sites
Domain
Manufacturing / Medical Devices (ISO 13485) / Automotive
Required skills
Quality system development, Regulatory compliance (ISO 13485), Customer relationship management, Process improvement, Audit management, Team coaching
Preferred skills
Automotive industry experience, OEM networking, Global regulatory landscape knowledge
Technologies
ISO 13485, Statistical process control
Responsibilities
Develop and maintain quality systems and compliance strategies; Coach QA chiefs on system effectiveness; Provide global regulatory advice and prepare for inspections; Monitor external QA landscape and industry bodies; Ensure compliance with Good Housekeeping and hygiene practices; Work with R&D on new product start-ups and establish checkpoints; Interface with manufacturing, engineering, and customer representatives.
Seniority
Senior, strategic leadership & mentorship