Senior Quality Engineer, Medical Device Production

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

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.