Senior Production Quality Engineer – Medical Devices

INBRAIN Neuroelectronics; Barcelona; Presencial; EUR 70.000 - 110.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Private Health Insurance

Training bonus

23 vacation days per year

Christmas week off

Descripción de la vacante

INBRAIN Neuroelectronics seeks a Senior Quality Engineer (Production) to lead production quality across manufacturing and microfabrication, ensuring compliant, robust processes for safe medical devices. The role involves owning critical quality workstreams, guiding external partners, and driving continuous improvement.

The position will be mainly office-based, Bellaterra in 2026 and Barcelona PCB from 2027.

Formación

• Bachelor’s degree in Biomedical Engineering, Industrial Engineering, Materials Science, Micro/Nanotechnology, Life Sciences or a related technical field.
• 5+ years of experience in quality engineering within a regulated manufacturing environment, preferably medical devices.
• Strong experience with process validation, equipment qualification and manufacturing process controls.
• Working knowledge of ISO 13485 requirements for production, infrastructure, work environment, monitoring and measurement equipment, process validation, traceability, nonconforming product and CAPA.
• Demonstrated experience leading nonconformity investigations, root-cause analysis and CAPA.
• Ability to mentor and provide technical guidance to Quality Engineers and manufacturing personnel.

Responsabilidades

• Own and continuously improve production quality controls across manufacturing and microfabrication processes.
• Support line clearance, contamination control, environmental conditions and traceability.
• Oversee cleanroom quality, access controls and environmental monitoring.
• Oversee equipment qualification, calibration and maintenance compliance.
• Lead validation activities with defined criteria, protocols and reports.
• Review manufacturing and inspection records for completeness and traceability.
• Lead complex nonconformity investigations and drive CAPA and effectiveness verification.
• Provide quality oversight for suppliers and CMOs and drive corrective actions.
• Analyze production quality performance and translate data into actionable improvements.
• Mentor Quality Engineers and manufacturing staff on GDP/GMP-like practices and risk management.

Conocimientos

Quality engineering

ISO 13485

Process validation

CAPA & RCA

Equipment qualification

Cross-functional teamwork

Mentoring

Written English

Educación

Bachelor's in related field

Herramientas

IQ/OQ/PQ

Descripción del empleo

INBRAIN Neuroelectronics seeks a Senior Quality Engineer (Production) to lead production quality across manufacturing and microfabrication, ensuring compliant, robust processes for safe medical devices. The role involves owning critical quality workstreams, guiding external partners, and driving continuous improvement.

The position will be mainly office-based, Bellaterra in 2026 and Barcelona PCB from 2027.