Sr. Manager, Design Assurance Engineering
Core
Strategic leader driving product quality, regulatory compliance, and innovation for dental electromechanical devices across the full product lifecycle.
Role type
Senior Manager, Design Assurance Engineering
Builds
Dental electromechanical devices and materials
Domain
Medical Devices / Dental / Regulatory Quality
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Strategic leadership, global design quality strategy, supplier quality management, regulatory compliance (FDA/ISO), risk management, validation (IQ/OQ/PQ), continuous improvement, digital quality systems, data analytics, root cause analysis
Preferred skills
Master's degree, global matrix environment experience, dental device expertise, Six Sigma Black Belt, ASQ CQE/CQA, AI/automation tools
Technologies
eQMS, eDHR, AI-driven quality solutions, predictive analytics
Responsibilities
Lead and mentor Design Assurance and Supplier Quality teams; Set strategic direction for global design quality; Drive innovation in quality engineering and digital transformation; Oversee design transfer, process validation, and lifecycle management; Own global Supplier Quality Management program; Lead complex root cause investigations and CAPA implementation; Ensure adherence to global regulatory requirements; Partner with R&D, Manufacturing, and Supply Chain to integrate quality.
Seniority
Senior Manager, strategic leadership with global scope
