Senior Production Quality Lead – Medical Devices

Inbrain Neuroelectronics; Bellprat; Presencial; EUR 70.000 - 100.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Private Health Insurance

23 vacation days

Christmas week off

Descripción de la vacante

Inbrain Neuroelectronics seeks a Senior Quality Engineer (Production) to lead production quality controls across manufacturing and microfabrication, ensuring compliance with SOPs, PFMEAs, and QMS requirements. You will be the technical partner to manufacturing and external CMOs, driving robust quality across processes.

The role requires 5+ years in quality engineering within regulated manufacturing, with strong validation, CAPA and documentation skills.

Formación

• 5+ years in quality engineering within a regulated manufacturing environment (medical devices).
• Strong experience with process validation and equipment qualification.
• Fluent English; capable of writing controlled documents and reports.

Responsabilidades

• Own production quality controls across manufacturing and microfabrication processes.
• Lead nonconformity investigations and CAPA with effectiveness verification.
• Oversee calibration, maintenance, and qualification of critical equipment.
• Provide technical coaching to Quality Engineers and manufacturing staff.

Conocimientos

Production quality leadership

Quality risk management

CAPA and root-cause analysis

IQ/OQ/PQ validation

GMP/ISO 13485 knowledge

Cross-functional collaboration

Documentation quality

Supplier quality oversight

Educación

Bachelor's degree in Biomedical/Industrial Engineering

Herramientas

eQMS

Statistical tools (SPC)

MS Office / Excel

Descripción del empleo

Inbrain Neuroelectronics seeks a Senior Quality Engineer (Production) to lead production quality controls across manufacturing and microfabrication, ensuring compliance with SOPs, PFMEAs, and QMS requirements. You will be the technical partner to manufacturing and external CMOs, driving robust quality across processes.

The role requires 5+ years in quality engineering within regulated manufacturing, with strong validation, CAPA and documentation skills.