Staff (Quality Engineer 5) - New Product Development
Core
Drives enterprise-level quality outcomes by leading strategic initiatives, shaping quality practices, and influencing decisions across business units for new product development.
Role type
Staff Quality Engineer (Strategic Leadership & Technical Authority)
Builds
Enterprise quality standards, frameworks, and methodologies adopted across multiple business units or sites.
Domain
Medical Devices / Robotic Surgery / Quality Engineering
Required skills
Strategic quality leadership, Advanced data analysis, Regulatory compliance (GMP, ISO, FDA), Risk management, Design controls, Mentorship, Cross-functional influence
Preferred skills
Experience with design verification/validation, Human factors engineering, Continuous improvement projects
Technologies
Quality management systems, Risk management tools, Design control software
Responsibilities
Lead initiatives changing quality execution across multiple BUs; Establish enterprise-wide quality standards and frameworks; Own high-impact product quality and compliance risks; Lead critical product, process investigations, audits, and CAPAs; Author and approve QA documentation and protocols; Analyze advanced quality data and KPI trends; Mentor junior and senior engineers; Ensure compliance with regulatory standards; Manage design controls, risk management, and design verification/validation for new products; Facilitate transfer of scalable designs to manufacturing.
Seniority
Staff, strategic leadership with hands-on technical authority
