Senior Quality Engineer (Production)

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).

What You'll Do

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, product qualityand 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 controlsand 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 monitoringand 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 decisionsand 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, deviationsand reports, ensuring that validation evidence is scientifically and statistically justified, traceable and sufficient to demonstrateprocess capability and control.
• Own the quality review of critical manufacturing and inspection records, assessing completeness, traceability, data integrityand 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, cleanroom activitiesand 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 actions wheresupplier performance impacts product quality or manufacturing robustness.
• Own and analyze production quality performance indicators, including nonconformities, yield, inspection results, equipment status, calibration compliance, environmental excursionsand 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, cleanroom behaviorsand 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 approachesand deliverables, proactively identifyrisksand ensure timelyresolution of quality-related issues.
• Support internal audits, external audits and notified body/FDA-readiness activities for production, infrastructure, equipment, work environment, monitoringand measurement controls.

Mandatory Qualifications and Soft skills:

• Bachelor’s degree in Biomedical Engineering, Industrial Engineering, Materials Science, Micro/Nanotechnology, Life Sciencesor a relatedtechnical field.
• 5+ years of experience in quality engineering within a regulated manufacturing environment, preferably medical devices, with demonstratedownership of complex production quality activities.
• Strong experience with process validation, equipment qualificationand manufacturing process controls.
• Working knowledge ofISO 13485 requirements for production, infrastructure, work environment,monitoringand measurement equipment, process validation, traceability,nonconformingproductand CAPA.
• Demonstrated experience leading nonconformity investigations, root-cause analysis, CAPA and effectiveness verification.
• Demonstrated ability to drive quality improvements and implement sustainable corrective actions across manufacturing processes.
• Experience with production controls, inspection records, batch records, DMR/DHR documentation or equivalent manufacturing quality evidence.
• Experience supporting equipment calibration, maintenance, qualification, verificationor validation activities.
• Experience working cross-functionally with Manufacturing, Development, Supply Chainand external suppliers or CMOs.
• Ability to review technical documentation, acceptance criteria, test records, deviationsand quality reports with strong attention to detail.
• Ability to mentor and providetechnical guidance to less experienced Quality Engineers and manufacturing personnel.
• Fluent professional English; ability to write controlled documents, reports, deviationsand quality records clearly and objectively.
• High attention to detail and strong ownership of documentation quality.
• Pragmatic, risk-based decision making in a fast-moving development-to-production environment.
• Ability to work hands-on with production, engineering, facilities, suppliers and Quality stakeholders.
• Clear communication and assertiveness to stop, escalate or contain activities when product quality or compliance may be impacted.
• Structured problem-solving mindset for deviations, equipment issues, monitoring excursions and process variability.
• Comfortable with ambiguity, continuous improvement and building scalable quality processes.

Nice to have (optional):

• Experience with cleanroom or controlled-environment manufacturing, including ISO-classified areas, gowning, particle monitoring, environmental monitoring and contamination control.
• Experience in microfabrication, semiconductor processes, thin-film processes, electrochemical processes, microassembly, implantable devices or active medical devices.
• Knowledge of EU MDR 2017/745, FDA 21 CFR 820 / QMSR, ISO 14971, validation master plans, process validation and test method validation.
• Experience with eQMS systems such as Dot Compliance, Master Control, Veeva Vault, etc. and with MES/ERP/PLM environments or implementation projects.
• Experience with supplier/CMO quality oversight, incoming inspection, final release controls, sterilization records or quality agreements.
• Training or practical knowledge in statistics, SPC, AQL sampling, capability analysis, yield monitoring or production KPIs.

What You'll Bring

Recruitment Process

• People & Culture Screening (30 min) - A brief introduction to learn about your background, career aspirations and interest in INBRAIN.
• Hiring Manager Interview (60-90 min) - A deeper discussion focused on your experience, technical expertise, and alignment with the role and team.
• Culture Fit Interview (60 min) - Conversations with key stakeholder and People & Culture Representative.

Why us?

We are looking for someone who Is ready to proactively bring new ideas to the team, push boundaries, and constantly look for innovation. At INBRAIN we believe in shared success and diverse ways of thinking, here you'll learn, grow, and advance in an innovative culture.

WHAT CAN WE OFFER TO YOU?

• A collaborative environment where innovative ideas flourish and teamwork drives us forward. At INBRAIN, we believe the power of collective intelligence is unique. You will be part of a team that thrives on open communication, knowledge sharing and mutual respect.
• Meaningful Work Impact: Our projects are not only exciting and challenging but also have a positive impact on the industry and society as a whole. You'll be part of a team that strives to create meaningful change.
• Cutting-Edge Technology Exposure: Joining us means immersing yourself in the latest technologies and innovative solutions. You'll have access to state-of-the-art tools and resources, fostering continuous learning and keeping your skills relevant in a rapidly evolving industry.
• Competitive salary (according to your experience/skills)
• Internal flexible compensation scheme
• Private Health Insurance
• Training bonus for professional development and access to Udemy platform
• 23 vacation days per year
• Christmas week off
• While we offer flexible working modality, because of the nature of this position, this will be an office-based position inBellaterra for 2026 and in Barcelona at PCB from 2027.

Applications must be submitted in English

At INBRAIN, we're not just offering a job - we're inviting you to be part of a transformative journey, Are you ready to transform lives? Join us!

#diverseandinclusive

We believe that a diverse and well-balanced workforce drives innovation. At INBRAIN, we foster the inclusion of all people regardless of culture, age, gender, sexual orientation and identity, or any other status