Experteer Overview
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 / Ventajas
• 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.

Responsabilidades
• Bachelor in Biomedical Engineering
• 2–3 years in a regulated manufacturing environment, medical device preferred
• Working knowledge of ISO 13485 and regulatory expectations (QC, traceability, CAPA)
• Experience with production controls, inspection/batch records and DMR/DHR documentation
• Experience supporting equipment calibration, maintenance, qualification, validation
• Strong attention to detail in reviewing technical docs, records and quality reports
• Fluent English; ability to write controlled documents and quality records clearly
• Hands-on collaboration with production, engineering, facilities, suppliers and QA

Requisitos principales
• private Health Insurance
• training bonus and Udemy access
• 23 vacation days per year
• Christmas week off
• internal flexible compensation scheme
• competitive salary

📌 Senior Quality Engineer (Production) (Barcelona)
🏢 Inbrain Neuroelectronics
📍 Barcelona