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 & 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 private Health Insurance training bonus and Udemy access

23 vacation days per year

Christmas week off internal flexible compensation scheme competitive salary

Responsabilidades

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.

Requisitos principales 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 high attention to detail clear and assertive communication structured problem-solving

ISO 13485 knowledge

DMR/DHR documentation

CAPA and deviation handling

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