Design Quality Assurance Expert
Core
Ensure design quality compliance and regulatory adherence for medical device design, development, and transfer throughout the product lifecycle.
Role type
Design Quality Assurance Expert
Builds
Quality assurance frameworks, design control deliverables, and regulatory documentation for dialysis products
Domain
Medical devices, renal care, regulatory compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Medical device design controls, regulatory compliance (NMPA, MDR, MDD, MDSAP), quality management systems (ISO 13485, ISO 14971, FDA 21 CFR 820.250), risk management, CAPA methodology, design history file (DHF) management, audit execution, design transfer oversight
Preferred skills
Statistical methods, cross-functional leadership, stakeholder management
Responsibilities
Review and approve design control deliverables and DHF documentation, support regulatory submission documentation, conduct design reviews and compliance audits, manage NCs and CAPAs, provide training on design controls, oversee design transfer activities
Seniority
Senior, 10 years experience desirable
