Role: Senior Quality Engineer (Production)Location: Barcelona area (2 days/week onsite, hybrid)Type: Permanent, full-timeOur 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 engine

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