Senior Design QA Engineer
Core
Lead end-to-end design control and new product development lifecycle as a quality core team lead for Companion Diagnostics (CDx) NPIs, ensuring products are designed, developed, and validated in compliance with regulatory requirements.
Role type
Senior Quality Assurance Team Lead (Regulated Medical Devices)
Builds
Companion Diagnostics (CDx) products for New Product Introductions (NPIs)
Domain
Life Sciences / Medical Devices / Companion Diagnostics
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Design control, Design Verification and Validation (V&V), Risk Management, Regulatory compliance (FDA, EMA), Quality management systems, cGMP, ISO 13485/14971, IEC 62366, EU IVDR
Preferred skills
Companion Diagnostics (CDx) experience, Clinical integration experience
Technologies
MS Office tools
Responsibilities
Lead and support design control activities across the full product development lifecycle, Ensure activities are conducted in compliance with all applicable regulatory requirements, Establish, maintain, and drive quality standards, Participate in team projects and assignments, facilitating or leading sub-teams as necessary
Seniority
Senior, hands-on IC
