• 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.

• 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.
• 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, verification or validation activities.
• Experience working cross-functionally with Manufacturing, Development, Supply Chain and external suppliers or CMOs.
• Ability to review technical documentation, acceptance criteria, test records, deviations and quality reports with strong attention to detail.
• Ability to mentor and provide technical guidance to less experienced Quality Engineers and manufacturing personnel.
• Fluent professional English; ability to write controlled documents, reports, deviations and 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.

• 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.

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 in Barcelona with occasional needs at Bellaterra location.