Senior Quality Engineer (Production) - Inbrain Neuroelectronics

Inbrain Neuroelectronics; Barcelona; Presencial; EUR 42.000 - 56.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Private Health Insurance

Training bonus and Udemy access

23 vacation days per year

Christmas week off

Descripción de la vacante

INBRAIN Neuroelectronics in Barcelona is seeking a Production Quality Engineer to ensure compliant manufacturing and QC for medical devices. You will support Quality & Regulatory with controls, calibration, environmental monitoring and documentation readiness in an office-based Barcelona role.

You will drive validation, CAPA and continuous improvement in a fast-paced, regulated environment with a focus on DMR/DHR documentation and lot release readiness.

Formación

• Bachelor in Biomedical Engineering; 2–3 years in a regulated manufacturing environment.
• Experience with ISO 13485 and regulatory expectations.
• Experience with production controls, inspection/batch records and DMR/DHR documentation.
• Fluent English; ability to write controlled documents clearly.

Responsabilidades

• Monitor production and microfabrication to ensure adherence to SOPs and QMS procedures.
• Oversee facility and cleanroom quality, including environmental monitoring and escalation of out-of-limit conditions.
• Manage equipment quality activities: registration, calibration, maintenance follow-up, IQ/OQ/PQ reviews.
• 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.

Conocimientos

Attention to detail

Structured problem solving

Communication

Collaboration

GMP/GDP knowledge

Educación

Bachelor in Biomedical Engineering

Herramientas

Descripción del empleo

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 13485 and regulatory expectations (QC, traceability, CAPA)
• Experience with production controls, inspection/batch records and DMR/DHR documentation
• 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) - INBRAIN Neuroelectronics barcelona, catalunya, es