Role: Senior Quality Engineer (Production) Barcelona area (2 days/week onsite, hybrid) Type: Permanent, full-time 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. Production quality controls across manufacturing and microfabrication: SOPs, control plans, PFMEAs, inspection criteria and QMS compliance Process and test method validation: defining and reviewing validation strategy, protocols, acceptance criteria and reports Equipment qualification and quality oversight: Cleanroom and facility quality oversight: gowning, contamination control, environmental monitoring,



escalation of out-of-limit conditions Nonconformity and quality investigations: structured root-cause analysis, CAPA definition and effectiveness verification Supplier and CMO quality oversight, including deviations, change notifications and manufacturing records Technical coaching of Quality Engineers and manufacturing personnel on production quality and cleanroom practices Bachelor's degree in Biomedical Engineering, Industrial Engineering, Materials Science, Micro/Nanotechnology, Life Sciences or a related technical field ~5+ 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 controls ~ Fluent professional English Cleanroom or controlled-environment manufacturing experience: ISO-classified areas, particle monitoring, environmental monitoring Background in microfabrication, semiconductor processes, thin-film, electrochemical processes or implantable/active medical devices Experience with eQMS platforms (Dot Compliance, Master Control, Veeva Vault) or MES/ERP/PLM environments

📌 Senior Quality Engineer - Performance (Cataluña)
🏢 Barrington James
📍 Cataluña