Senior Quality Engineer (Production)

Inbrain Neurolectronics; Barcelona; Presencial; EUR 65.000 - 95.000; Jornada completa

Descripción de la vacante

Inbrain Neurolectronics is seeking a Senior Quality Engineer (Production) to lead quality activities across production, microfabrication and final QC. The role ensures processes are controlled, compliant and capable of delivering safe medical devices.

The position is mainly office-based in Bellaterra, moving to Barcelona in 2027. You will drive risk-based improvements, manage audits, and support suppliers and CMOs with CAPA and quality documentation to enable manufacturing readiness and

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, monitoring and measurement equipment, process validation, traceability, nonconforming product and CAPA.
• Demonstrated ownership of complex production quality activities.

Responsabilidades

• Own and continuously improve production quality controls across manufacturing and microfabrication processes, ensuring alignment with SOPs, WINs, specifications and QMS requirements; drive corrective actions to improve robustness and readiness.
• Support implementation and maintenance of production controls, including line clearance, contamination control, environmental conditions, identification and traceability, prevention of product mix-up, in-process controls and final quality controls.
• Support facility and cleanroom quality oversight, including access controls, gowning and cleanliness practices, environmental monitoring and escalation of out-of-limit conditions.
• Own quality oversight for production and laboratory equipment, including qualification strategy, calibration and maintenance compliance, IQ/OQ/PQ review and risk-based actions.
• Own or provide technical leadership for process and test method validation activities within assigned manufacturing areas, with defined protocols and reports.
• Oversee quality review of critical manufacturing and inspection records for traceability and data integrity; drive improvements and DHR readiness.
• Lead complex nonconformity and quality investigations across production, facilities, equipment and suppliers with root-cause analysis and CAPA closure.
• Provide quality engineering oversight for suppliers and CMOs, including review of quality performance and deviations; drive corrective actions where needed.
• Own production quality performance indicators and translate data into actionable recommendations for leadership.
• Provide coaching to Quality Engineers and manufacturing personnel on GDP/GMP-like practices and risk management.

Conocimientos

Quality engineering

Regulated manufacturing

Root cause analysis

CAPA

Process validation

Equipment qualification

Educación

Bachelor's degree in Biomedical Engineering

Herramientas

QMS software

Descripción del empleo

Descripción del trabajo

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 a Senior 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. Identify systemic risks and drive corrective actions to improve process robustness, product quality and 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-process controls and 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, particle monitoring and 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, requalification decisions and 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 within assigned manufacturing areas. Define or review validation strategy, acceptance criteria, protocols, deviations and reports, ensuring that validation evidence is scientifically and statistically justified, traceable and sufficient to demonstrate process capability and control.
• Own the quality review of critical manufacturing and inspection records, assessing completeness, traceability, data integrity and compliance with approved requirements. Identify trends 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, cleanroom activities and 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. Identify recurring 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 actions where supplier performance impacts product quality or manufacturing robustness.
• Own and analyze production quality performance indicators, including nonconformities, yield, inspection results, equipment status, calibration compliance, environmental excursions and CAPA performance. Identify trends, 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, cleanroom behaviors and 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, technical approaches and deliverables, proactively identify risks and ensure timely resolution of quality-related issues.
• Support internal audits, external audits and notified body/FDA-readiness activities for production, infrastructure, equipment, work environment, monitoring and measurement controls.

Mandatory Qualifications and Soft skills:

• 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, with demonstrated ownership of complex production quality activities.
• 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.
• Demonstr