Senior Quality Engineer
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As a Production Quality Engineer at INBRAIN, you ensure compliant, traceable production, microfabrication and QC activities for medical device manufacturing. You will support Quality & Regulatory with production controls, calibration, environmental monitoring and documentation readiness. You help drive validation, CAPA and continuous improvement in a fast-paced, regulated environment. This office-based role in Barcelona offers exposure to cutting-edge neuroelectronic solutions and meaningful patient impact.
Compensaciones / Beneficios- private Health Insurance
- training bonus and Udemy access
- 23 vacation days per year
- Christmas week off
- internal flexible compensation scheme
- competitive salary
- Monitor production and microfabrication to ensure adherence to SOPs, specs, control plans and QMS procedures.
- Support production controls, line clearance, containment, environmental conditions, traceability, in-process and final quality controls.
- Oversee facility and cleanroom quality, including access, gowning, environmental monitoring and escalation of out-of-limit conditions.
- Manage equipment quality activities: registration, calibration, maintenance follow-up, qualification planning and IQ/OQ/PQ reviews.
- Draft/review validation plans and protocols; manage deviations, acceptance criteria and evidence packages.
- Review batch records, DHR-like evidence and release documentation to confirm lot disposition readiness.
- Investigate nonconformities; support root cause analysis, CAPA and continuous improvement.
- Support supplier/CMO quality oversight and review quality records, deviations and change notifications.
- Maintain quality KPIs and monitoring inputs related to nonconformities, yield, inspections and CAPA timeliness.
- Train and coach teams on GDP/GMP-like practices, documentation and quality expectations.
- Support internal/external audits and readiness activities for FDA/Notified Bodies and QMS.
- Bachelor in Biomedical Engineering
- 2–3 years in a regulated manufacturing environment, medical device preferred
- Working knowledge of ISO 13485 and regulatory expectations (QC, traceability, CAPA)
- Experience with production controls, inspection/batch records and DMR/DHR documentation
- Experience supporting equipment calibration, maintenance, qualification, validation
- Strong attention to detail in reviewing technical docs, records and quality reports
- Fluent English; ability to write controlled documents and quality records clearly
- Hands-on collaboration with production, engineering, facilities, suppliers and QA
- high attention to detail
- clear and assertive communication
- structured problem-solving
- ISO 13485 knowledge
- DMR/DHR documentation
- CAPA and deviation handling
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