Staff Quality Engineer - New Product Development
Core
Drives enterprise-level quality outcomes by leading strategic initiatives, shaping quality practices, and influencing decisions across business units to ensure compliance with regulatory standards (GMP, ISO, FDA) for new product development.
Role type
Staff Quality Engineer (New Product Development)
Builds
Scalable medical device designs and reliable manufacturing processes for robotic-assisted surgery systems
Domain
Medical Devices / Robotic Surgery / Quality Engineering
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Strategic quality leadership, regulatory compliance (GMP/ISO/FDA), risk management, design control stewardship, data analysis, mentorship, cross-functional influence
Preferred skills
Experience with design verification/validation, human factors engineering, continuous improvement methodologies
Technologies
Quality management systems, risk assessment tools, design traceability matrices
Responsibilities
Lead initiatives changing quality execution across business units, establish enterprise-wide quality standards, own quality investigations for complaints and non-conformances, mentor junior and senior engineers, partner with engineering to define design inputs and traceability, facilitate transfer of scalable designs to manufacturing
Seniority
Staff, enterprise-level strategic leadership