CDx Design Quality Senior Manager
Core
Lead a team of CDx Design Assurance Specialists to oversee design controls, risk management, verification, validation, and clinical performance evaluation for Companion Diagnostics products.
Role type
Senior IC/Manager, CDx Design Quality
Builds
Companion Diagnostics (CDx) products for medical use
Domain
Medical Devices / In Vitro Diagnostics (IVD) / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Design controls, risk management, verification and validation (V&V), clinical performance evaluation, Quality Management System (QMS) maintenance, regulatory compliance (FDA/IVDR/ISO13485), resource planning, cross-functional coordination, team leadership, audit participation, process improvement
Preferred skills
Experience in IVD/Medical Devices or pharmaceutical regulated industry, human factors engineering expertise, change management
Technologies
ISO13485, FDA CFR 21 820, IVDR
Responsibilities
Ensure effective implementation of design controls and quality processes; provide leadership for CDx development projects including V&V and risk management; approve quality documents and maintain QMS; support product investigations and regulatory interactions; lead QMS improvement initiatives; manage performance and development of team members; participate in internal and external audits; drive process efficiencies and establish best practices.
Seniority
Senior, hands-on IC with management responsibilities
