Engineer III, DQA (NPD)
Core
Develops and maintains quality engineering methodologies, systems, and practices to meet regulatory and customer requirements for new product development.
Role type
Senior IC Quality Engineering (NPD)
Builds
Medical device products and design change projects
Domain
Medical Devices / Quality Engineering
Required skills
Quality engineering methodologies, Design of Experiments (DOE), FMEA, Risk Management, Statistical testing, Regulatory compliance, CAPA, Six Sigma problem solving, Document control
Preferred skills
Stage gate review leadership, Vendor testing coordination, Usability and reliability planning
Technologies
Design of Experiments (DOE), FMEA, Six Sigma, CAPA, PLCP
Responsibilities
Lead quality engineering across the entire development cycle; Support development of CTQs, design input/output documents, and fixture qualification; Implement design verification and validation plans; Manage electronic document control and version control; Co-lead stage gate reviews and sign off on PDP document approvals; Provide quality and regulatory compliance guidance to project teams; Co-lead CAPA efforts using systematic problem-solving methodologies.