03 oct
|
Inbrain Neuroelectronics
|
Cataluña
03 oct
Inbrain Neuroelectronics
Cataluña
As a Production Quality Engineer at INBRAIN, you ensure compliant, traceable production, microfabrication and QC activities for medical device manufacturing. You will support Quality & 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. * private Health Insurance * training bonus and Udemy access * 23 vacation days per year * Christmas week off * 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. * 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. * Bachelor in Biomedical Engineering * 2–3 years in a regulated manufacturing environment, medical device preferred * Working knowledge of ISO
📌 Senior Quality Engineer (Cataluña)
🏢 Inbrain Neuroelectronics
📍 Cataluña