23 oct
|
Inbrain Neuroelectronics
|
Barcelona
23 oct
Inbrain Neuroelectronics
Barcelona
Your mission
We are scientists, doctors, techies and humanity lovers, with the mission of building neuroelectronic interfaces to cure brain disorders. INBRAIN harnesses the extraordinary material properties of Graphene, the world’s thinnest and nobel-prize winning material, to build safe, uninvasive and highly efficient neural solutions.
Our mission is to decode and modulate neural networks to improve people's lives
As aSenior Quality Engineer (Production), you will provide technical quality leadership across INBRAIN’s production, microfabrication and final quality control activities, ensuring that manufacturing processes are controlled, compliant, robust and capable of consistently delivering safe and high-quality medical devices. The role owns complex production quality workstreams and acts as a key technical partner to stakeholders in business areas like manufacturing or microfabrication, and external manufacturing partners.
You will be at the forefront of bringing advanced healthcare solutions to market, making a tangible difference in people´s lives worldwide.
This position will be mainly office-based (Bellaterra based for 2026, Barcelona at PCB from 2027).
Your profile
Main
responsibilities:
- Own and continuously improve production quality controls across assigned manufacturing and microfabrication processes, ensuring alignment with approved SOPs, WINs, specifications, control plans, PFMEAs, inspection criteria and QMS requirements.
Identifysystemic risks and drive corrective actions to improve process robustness, productqualityand manufacturing readiness.
- Support implementation and maintenance of production controls, including line clearance, contamination control, environmental conditions, identification and traceability, prevention of product mix-up,
in-processcontrolsand final quality controls.
- Support facility and cleanroom quality oversight, including access controls, gowning and cleanliness practices, material/equipment entry controls, environmental monitoring, temperature/humidity/pressure controls, particlemonitoringand escalation of out-of-limit conditions.
- Own quality oversight for critical production and laboratory equipment, including qualification strategy, calibration and maintenance compliance, IQ/OQ/PQ review, requalificationdecisionsand equipment-related deviations.
Assess the quality impact of equipment changes and failures and ensure appropriate risk-based actions are implemented.
- Own or provide technical leadership for process and test method validation activities withinassigned manufacturing areas. Define or review validation strategy, acceptance criteria, protocols,deviationsand reports, ensuring that validation evidence is scientifically and statistically justified, traceable and sufficient todemonstrateprocess capability and control.
- Own the quality review of critical manufacturing and inspection records, assessing completeness, traceability, dataintegrityand compliance with approved requirements.
Identifytrends and systemic documentation or process weaknesses and drive improvements to manufacturing quality records and DHR readiness.
- Lead complex nonconformity and quality investigations across production, facilities, equipment, cleanroomactivitiesand suppliers. Drive structured root-cause analysis, define effective corrective and preventive actions, challenge proposed root causes when evidence is insufficient, and own effectiveness verification through closure.
Identifyrecurring or systemic issues and translate them into sustainable process and quality improvements.
- Provide quality engineering oversight for assigned suppliers and CMOs, including review of quality performance, deviations, change notifications, calibration and maintenance evidence and manufacturing records. Lead or contribute to supplier quality investigations and drive corrective actionswheresupplier performance impacts product quality or manufacturing robustness.
- Own and analyze production quality performance indicators, including nonconformities, yield, inspection results, equipment status, calibration compliance, environmentalexcursionsand CAPA performance.
Identifytrends, recurring issues and opportunities for improvement and translate quality data into actionable recommendations for Manufacturing and QARA leadership.
- Provide technical coaching and guidance to Quality Engineers and manufacturing personnel on production quality, GDP/GMP-like practices, deviation investigation, documentation, cleanroombehaviorsand quality risk management. Raise quality standards across the production organization through knowledge sharing and best practices.
- Own quality engineering workstreams for complex production and manufacturing-readiness initiatives, coordinating activities across Manufacturing, Microfabrication,Development, Supply Chain,QARA, etc.
Define priorities, technicalapproa
📌 Senior Quality Engineer (Barcelona)
🏢 Inbrain Neuroelectronics
📍 Barcelona