Senior Quality Engineer (Les)

Senior Quality Engineer (Les)

22 sep
|
Barrington James
|
Les

22 sep

Barrington James

Les

OverviewRevise detenidamente toda la documentación de la solicitud antes de hacer clic en el botón de solicitar al final de esta descripción.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 / Beneficiosprivate Health Insurancetraining bonus and Udemy access23 vacation days per yearChristmas week offinternal versátil compensation schemecompetitive salaryResponsabilidadesMonitor 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. xhfqzwm 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 principalesBachelor in Biomedical Engineering2–3 years in a regulated manufacturing environment, medical device preferredWorking knowledge of ISO 13485 and regulatory expectations (QC, traceability, CAPA)Experience with production controls, inspection/batch records and DMR/DHR documentationExperience supporting equipment calibration, maintenance, qualification, validationStrong attention to detail in reviewing technical docs, records and quality reportsFluent English; ability to write controlled documents and quality records clearlyHands-on collaboration with production, engineering, facilities, suppliers and QAhigh attention to detailclear and assertive communicationstructured problem-solvingISO 13485 knowledgeDMR/DHR documentationCAPA and deviation handling

📌 Senior Quality Engineer (Les)
🏢 Barrington James
📍 Les

Postulate a este anuncio

Muestra tus habilidades a la empresa, rellenar el formulario y deja un toque personal en la carta, ayudará el reclutador en la elección del candidato.

Suscribete a esta alerta:

Recibe por email las nuevas ofertas de trabajo para: senior quality engineer (les) / les

Suscribete a esta alerta:

Recibe por email las nuevas ofertas de trabajo para: senior quality engineer (les) / les