Senior Quality Engineer (Barcelona)

Senior Quality Engineer (Barcelona)

04 nov
|
Inbrain Neuroelectronics
|
Barcelona

04 nov

Inbrain Neuroelectronics

Barcelona

About the Company
▪️Who we are At Inbrain Neuroelectronics, we built our company around a simple belief: outstanding impact needs outstanding people. Our mission is to transform the treatment of neurological disorders through neuroelectronic therapies that are safer, smarter, and more human‑centered. We work at the intersection of neuroscience, engineering, and advanced materials, but what truly drives us is the impact our work can have on patients’ lives. Our culture is grounded in Integrity First—we hold ourselves to the highest ethical standards because the people we serve deserve nothing less. We are Human Powered, valuing empathy, collaboration, and the diverse perspectives that make our ideas stronger. We encourage everyone to think like Game Changers, challenging assumptions and pushing boundaries to unlock breakthroughs that once felt out of reach.
We act with Conscious Impact, aware that every decision—from research to clinical translation—shapes real futures. And we embrace a Growth Mindset ,creating an environment where learning is continuous, curiosity is celebrated, and people are supported to stretch beyond their comfort zones. At Inbrain, you’ll join a team united by purpose and energized by possibility. If you’re looking for a place where your talent can contribute to meaningful change—and where you can grow while helping others thrive—you’ll feel at home here.

About the Role
▪️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
Production Quality Controls & Manufacturing Readiness
• Lead and continuously improve quality controls across assigned manufacturing and microfabrication processes, ensuring alignment with approved procedures, work instructions, specifications, control plans, PFMEAs, risk controls and QMS requirements. Identify systemic risks and drive actions to improve process robustness, product quality and manufacturing readiness.
• Drive the 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 inspection activities.
• Own the design and process transfer, scale-up and manufacturing readiness activities, ensuring that production specifications, inspection methods, validation evidence, risk controls, training requirements and manufacturing documentation are adequately established before routine production.
• Lead Quality Engineering oversight of manufacturing and inspection records, with a focus on traceability, data integrity, documentation robustness and DHR readiness. Identify recurring documentation issues or systemic weaknesses and drive improvements to manufacturing records, inspection records and production documentation processes.
• Define Quality review of production changes, assessing potential impacts to validated state, product conformity, risk controls, traceability, regulatory commitments and manufacturing readiness.
• Partner closely with Manufacturing, Microfabrication, Device Development and Supply Chain to ensure production processes remain controlled and capable throughout the product lifecycle. Validation,



Equipment & Measurement Systems
• Lead independent Quality oversight of process, equipment and test method validation activities within assigned manufacturing areas.
• Define and govern validation strategies, risk-based acceptance criteria, protocols, deviations and reports, ensuring that validation evidence is scientifically and statistically justified, traceable to applicable requirements and sufficient to demonstrate process capability and control.
• Drive Quality oversight of critical production and laboratory equipment, including qualification activities, calibration and maintenance compliance, requalification decisions and assessment of the impact of equipment changes or failures on product quality and process control.
• Ensure production inspection and measurement methods are suitable for their intended use, including verification, validation and measurement system assessments where applicable.
• Own the maintenance of validated processes and qualified equipment through periodic review, change assessment and risk-based decision making. Nonconformity, CAPA & Change Control
• Lead complex nonconformity investigations related to production, equipment, facilities, cleanroom activities and manufacturing processes.
• Apply structured root-cause analysis methodologies, challenge unsupported conclusions and ensure corrective and preventive actions are evidence-based and proportionate to risk.
• Establish the effectiveness of implemented corrective actions and identify recurring or systemic issues requiring broader process improvements.
• Drive manufacturing change control activities and assess the quality impact of proposed process, equipment, material, supplier, facility and inspection method changes.
• Escalate significant quality issues, trends or validation gaps that may affect product safety, compliance, release readiness, manufacturing continuity or approved risk controls. Cleanroom & Contamination Control Oversight
• Own Quality Engineering oversight of controlled environments and cleanroom activities within assigned manufacturing areas.
• Lead implementation and maintenance of contamination-control measures, including personnel practices, gowning, cleanliness controls, material and equipment entry controls, environmental monitoring and response to environmental excursions.
• Review environmental monitoring data, identify adverse trends and ensure appropriate investigations, risk assessments and corrective actions are performed when limits are exceeded.
• Drive compliant behaviours and contamination-control awareness through coaching, training support and continuous improvement initiatives.
• Support qualification and ongoing monitoring of facilities and controlled environments as required. Supplier & CMO Production Quality
• Lead Quality Engineering oversight of production-related suppliers and contract manufacturing organizations (CMOs) whose activities may affect product quality, manufacturing robustness or supply continuity.
• Define supplier qualification, audit follow-up, quality performance monitoring, investigation activities, supplier change assessments and implementation of risk control plans.
• Analyze and drive supplier-related deviations, nonconformities and corrective actions, ensuring appropriate risk-based resolution when supplier performance impacts product quality.
• Drive alignment with Supply Chain and Supplier Quality functions to ensure supplier controls remain effective and aligned with applicable regulatory and quality requirements.
• Own external manufacturing transfers, manufacturing readiness assessments and quality oversight of outsourced production activities. Quality Metrics, Continuous Improvement & Technical Leadership
• Lead the production quality performance metrics, including nonconformities, process trends, inspection results, environmental monitoring, validation status,



equipment compliance and CAPA effectiveness.
• Translate quality data into actionable recommendations that improve process capability, quality performance, manufacturing readiness and operational effectiveness.
• Drive technical coaching and mentorship to Quality Engineers and production personnel on production quality, risk management, investigations, controlled manufacturing practices, documentation and quality systems.
• Lead or support cross-functional quality improvement initiatives aimed at reducing risk, strengthening controls and improving quality culture.
• Establish and maintain internal audits, external audits, notified body inspections and FDA readiness activities related to manufacturing operations, facilities, equipment, process controls and monitoring activities.
• Act as the primary Quality Engineering partner for assigned manufacturing areas, providing independent quality judgement while working collaboratively with operational stakeholders. ▪️What We're Looking For
• Bachelor's degree in biomedical engineering, Industrial Engineering, Materials Science, Micro/Nanotechnology, Life Sciences or a related technical field.
• Over +7 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 with sterile medical devices, microbiological controls and biohazard.
• 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. What's in it for you?
• 23 days of annual holiday
• Company-wide Christmas Break
• Private health insurance
• Adaptable compensation benefits through Payflow
• Free Spanish classes
• Udemy learning account
• Annual training allowance to support your professional development
• A high-tech, state-of-the-art office designed for collaboration and innovation
• Flexible and dynamic work environment with the opportunity to grow alongside the company About the 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. Equal Opportunity Statement At INBRAIN, we believe that diverse perspectives drive innovation and lead to better outcomes for our team, our technology, and the patients we serve. We are committed to fostering an inclusive workplace where everyone is valued, respected, and empowered to succeed. We welcome applications from all qualified candidates regardless of race, ethnicity, nationality, gender identity or expression, sexual orientation, age, disability, religion, or any other protected characteristic. We encourage individuals from underrepresented backgrounds to apply, even if they do not meet every qualification listed, as we recognize that talent and potential come in many forms. To ensure a positive candidate experience, we aim to provide a transparent, efficient, and respectful hiring process, with timely communication and feedback throughout.

📌 Senior Quality Engineer (Barcelona)
🏢 Inbrain Neuroelectronics
📍 Barcelona

Postulate a este anuncio

Muestra tus habilidades a la empresa, rellenar el formulario y deja un toque personal en la carta, ayudará el reclutador en la elección del candidato.

Suscribete a esta alerta:

Recibe por email las nuevas ofertas de trabajo para: senior quality engineer (barcelona) / barcelona

Suscribete a esta alerta:

Recibe por email las nuevas ofertas de trabajo para: senior quality engineer (barcelona) / barcelona