Production Quality Engineer

Sobre el puesto

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.

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…