Staff (Quality Engineer 5) - New Product Development
Core
Drives enterprise-level quality outcomes by leading strategic initiatives, establishing standards, and ensuring compliance with regulatory frameworks (GMP, ISO, FDA) for new product development.
Role type
Staff Quality Engineer (Strategic & Technical Leadership)
Builds
Enterprise quality frameworks, design controls, risk management files, and scalable product designs for manufacturing transfer.
Domain
Medical Device Industry / Quality Engineering / New Product Development
Required skills
Strategic quality leadership, regulatory compliance (GMP/ISO/FDA), design control stewardship, risk management, advanced data analysis, mentorship, cross-functional influence
Preferred skills
Experience with robotic-assisted surgery systems, user needs translation, design verification/validation strategy
Technologies
Quality management systems, risk assessment tools, design traceability matrices
Responsibilities
Lead cross-BU quality initiatives and establish enterprise standards; Own quality investigations for complaints and non-conformances; Steward design controls and risk management for new products; Mentor senior engineers; Ensure compliance with regulatory standards; Analyze quality data and KPI trends.
Seniority
Staff, strategic leadership & technical authority
