Role: Senior Quality Engineer (Production)Location: Barcelona area (2 days/week onsite, hybrid)Type: Permanent, full-timeSi cree que es el candidato ideal para la siguiente ocasión, envíe su solicitud después de leer la descripción completa.Our client is a fast-growing medical technology company based in Barcelona, developing next-generation implantable neurotechnology to treat neurological disorders. They are scaling their production and microfabrication operations and are looking for a Senior Quality Engineer to take technical ownership of production quality across manufacturing and final QC.This is a senior, hands-on individual contributor role, not a management position. You will be the technical quality partner to Manufacturing and Microfabrication, working directly with external partners and cross-functional stakeholders to keep production processes controlled, compliant and consistently capable of delivering safe, high-quality medical devices.What you'll ownProduction quality controls across manufacturing and microfabrication: SOPs, control plans, PFMEAs, inspection criteria and QMS complianceProcess and test method validation: defining and reviewing validation strategy, protocols, acceptance criteria and reportsEquipment qualification and quality oversight: IQ/OQ/PQ review, calibration compliance, requalification decisionsCleanroom and facility quality oversight: gowning, contamination control, environmental monitoring, escalation of out-of-limit conditionsNonconformity and quality investigations: structured root-cause analysis, CAPA definition and effectiveness verificationSupplier and CMO quality oversight,



including deviations, change notifications and manufacturing recordsTechnical coaching of Quality Engineers and manufacturing personnel on production quality and cleanroom practicesSupport for internal and external audits, including notified body and FDA-readiness activitiesWhat we're looking forBachelor's degree in Biomedical Engineering, Industrial Engineering, Materials Science, Micro/Nanotechnology, Life Sciences or a related technical field5+ years in quality engineering within a regulated manufacturing environment, medical device strongly preferred, with real ownership of production quality activities (not just support)Strong hands-on experience with process validation, equipment qualification and manufacturing process controlsWorking knowledge of ISO 13485 as applied to production, traceability, nonconforming product and xqziphu CAPAA track record of leading nonconformity investigations through to effectiveness verificationComfort working cross-functionally with Manufacturing, Development, Supply Chain and external suppliers/CMOsFluent professional EnglishEspecially strong fit if you also have:Cleanroom or controlled-environment manufacturing experience: ISO-classified areas, particle monitoring, environmental monitoringBackground in microfabrication, semiconductor processes, thin-film, electrochemical processes or implantable/active medical devicesKnowledge of EU MDR 2017/745, FDA 21 CFR 820/QMSR, ISO 14971Experience with eQMS platforms (Dot Compliance, Master Control, Veeva Vault) or MES/ERP/PLM environmentsPlease apply directly if you're interested.

📌 Customer Quality Engineer (España)
🏢 Barrington James
📍 España