Senior Quality Engineer (Production)

• 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 protocolsdeviationsand 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 MicrofabricationDevelopment Supply ChainQARA etc.Define priorities technicalapproachesand deliverables proactivelyidentifyrisksand ensuretimelyresolution of quality-related issues.
• Support internal audits external audits and notified body/FDA-readiness activities for production infrastructure equipment work environmentmonitoringand measurement controls.

• Bachelors degree in Biomedical Engineering Industrial Engineering Materials Science Micro/Nanotechnology LifeSciencesora relatedtechnical field.
• 5 years of experience in quality engineering within a regulated manufacturing environment preferably medical devices withdemonstratedownership of complex production quality activities.
• Strong experience with process validation equipmentqualificationand manufacturing process controls.
• Working knowledge ofISO 13485 requirements for production infrastructure work environmentmonitoringand measurement equipment process validation traceabilitynonconformingproductand 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/DHRdocumentation or equivalent manufacturing quality evidence.
• Experience supporting equipment calibration maintenance qualificationverificationor validation activities.
• Experience working cross-functionally with ManufacturingDevelopmentSupplyChainand external suppliers or CMOs.
• Ability to review technical documentation acceptance criteria test recordsdeviationsand quality reports with strong attention to detail.
• Ability to mentor andprovidetechnical guidance to less experienced Quality Engineers and manufacturing personnel.
• Fluent professional English; ability to write controlled documents reportsdeviationsand 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.

WHAT CAN WE OFFER TO YOU

• Acollaborative 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. Youll 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. Youll 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.