19 sep
|
Inbrain Neuroelectronics
|
Barcelona
19 sep
Inbrain Neuroelectronics
Barcelona
Experteer Overview
Aumente sus posibilidades de conseguir una entrevista leyendo la siguiente descripción general de este puesto antes de presentar su candidatura.
As a Production Quality Engineer at INBRAIN, you ensure compliant, traceable production, microfabrication and QC activities for medical device manufacturing. You will support Quality u0026amp; Regulatory with production controls, calibration, environmental monitoring and documentation readiness. You help drive validation, CAPA and continuous improvement in a fast-paced, regulated environment. This office-based role in Barcelona offers exposure to cutting-edge neuroelectronic solutions and meaningful patient impact.
Compensaciones / Incentivos
• Monitor production and microfabrication to ensure adherence to SOPs, specs, control plans and QMS procedures.
• Support production controls, line clearance, containment, environmental conditions, traceability, in-process and final quality controls.
• Oversee facility and cleanroom quality, including access, gowning, environmental monitoring and escalation of out-of-limit conditions.
• Manage equipment quality activities: registration, calibration, maintenance follow-up, qualification planning and IQ/OQ/PQ reviews.
• Draft/review validation plans and protocols; manage deviations, acceptance criteria and evidence packages.
• Review batch records, DHR-like evidence and release documentation to confirm lot disposition readiness.
• Investigate nonconformities; support root cause analysis, CAPA and continuous improvement.
• Support supplier/CMO quality oversight and review quality records, deviations and change notifications.
• Maintain quality KPIs and monitoring inputs related to nonconformities, yield, inspections and CAPA timeliness. xghoner
• Train and coach teams on GDP/GMP-like practices, documentation and quality expectations.
• Support internal/external audits and readiness activities for FDA/Notified Bodies and QMS.
Responsabilidades
• Bachelor in Biomedical
📌 Senior Quality Engineer (Barcelona)
🏢 Inbrain Neuroelectronics
📍 Barcelona