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 Production Quality Engineer, you will oversee that the production, microfabrication and final quality control activities are performed under controlled, compliant and traceable conditions for medical device manufacturing. This role will support the Quality & Regulatory function by overseeing: production quality controls, facilities and cleanroom-related controls, equipment calibration and qualification, environmental monitoring, process validation support, manufacturing documentation, DMR/DHR readiness, and release evidence for internal and outsourced manufacturing activities.

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 in Barcelona with occasional needs at Bellaterra location.

Your profile

Main responsibilities:

• Monitor production and microfabrication activities to ensure compliance with approved SOPs, WINs, specifications, control plans, PFMEAs, inspection criteria and applicable QMS procedures.
• 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 or support equipment quality activities: equipment registration, status labelling, calibration and maintenance follow-up, qualification planning and review, IQ/OQ/PQ protocol and report review, requalification assessment after changes, and management of equipment-related deviations.
• Support process validation and test method validation activities by drafting/reviewing validation plans, protocols, acceptance criteria, deviations, reports and evidence packages.
• Review manufacturing and inspection records, final control reports, calibration evidence, certificates, batch documentation and DHR-like evidence to confirm completeness before lot disposition or escalation to QA/PRRC release.
• Investigate and document nonconformities related to production, facilities, equipment, monitoring, cleanroom activities and suppliers; support root cause analysis, CAPA, effectiveness checks and continuous improvement.
• Support supplier and CMO oversight for production-related controls, including review of quality records, deviations, certificates, calibration/maintenance evidence and change notifications.
• Maintain quality KPIs and production monitoring inputs related to nonconformities, process yield, inspection results, equipment status, calibration compliance, environmental excursions and CAPA timeliness.
• Train and coach production, laboratory and microfabrication personnel on GDP, GMP-like practices, cleanroom behaviours, equipment status control, documentation practices and quality expectations.
• 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.
• Minimum 2–3 years of experience in a regulated manufacturing environment; medical device experience strongly preferred.
• Working knowledge of ISO 13485 requirements for production, infrastructure, work environment, monitoring and measurement equipment, process validation, traceability, nonconforming product and CAPA.
• 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.
• Ability to review technical documentation, acceptance criteria, test records, deviations and quality reports with strong attention to detail.
• Fluent professional English; ability to write controlled documents, reports, deviations and quality records clearly and objectively (company´s culture language)
• 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.

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 in Barcelona with occasional needs at Bellaterra location.

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