Senior Quality Engineer (Production)
Core
Provide technical quality leadership across production, microfabrication, and final quality control to ensure manufacturing processes are compliant, robust, and capable of delivering safe medical devices.
Role type
Senior Quality Engineer (Production)
Builds
Safe and high-quality medical devices using graphene-based neuroelectronic interfaces
Domain
Medical devices / Neuroelectronics / Microfabrication
Required skills
Process validation, Equipment qualification, Manufacturing process controls, Root-cause analysis, CAPA management, Supplier quality oversight, Cleanroom quality oversight, Data integrity, Risk-based decision making, Technical documentation review
Preferred skills
Cleanroom manufacturing experience, Microfabrication/semiconductor processes, EU MDR/FDA regulations knowledge
Technologies
ISO 13485, IQ/OQ/PQ, PFMEA, DHR/DMR
Responsibilities
Own and improve production quality controls across manufacturing and microfabrication processes; Support implementation of production controls including line clearance and contamination control; Own quality oversight for critical production and laboratory equipment; Lead process and test method validation activities; Lead complex nonconformity and quality investigations; Provide quality engineering oversight for assigned suppliers and CMOs; Support internal and external audits for production and FDA-readiness.
Seniority
Senior, hands-on IC