Advanced Engineer DQA
Core
Own project management and product development testing strategies to minimize failures during new product introduction (NPI) and ensure quality compliance.
Role type
Senior Quality Assurance Engineer (Medical Devices)
Builds
Medical device products and validated processes
Domain
Medical Devices / Quality Engineering
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
statistical quality tools, CAPA/SCAR management, supplier quality management, regulatory compliance (510k, CE), risk management, design control, change request evaluation, supplier coordination, laboratory testing coordination
Preferred skills
process validation, continuous improvement, cost efficiency analysis
Technologies
statistical quality tools, Device Master Records, technical files
Responsibilities
Define testing strategies for NPI, develop standardized process control methods, execute experimental testing and data analysis, resolve customer complaints with suppliers, manage supplier change requests, establish compliant product documentation, conduct quality reviews of design documentation, coordinate product testing with laboratories
Seniority
Senior, hands-on IC
