Role:

Senior Quality Engineer (Production) Location:

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.

What you'll own 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: IQ/OQ/PQ review, calibration compliance, requalification decisions 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 Support for internal and external audits, including notified body and FDA-readiness activities

What we're looking for 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 Working knowledge of ISO 13485 as applied to production, traceability, nonconforming product and CAPA A track record of leading nonconformity investigations through to effectiveness verification Comfort working cross-functionally with Manufacturing, Development, Supply Chain and external suppliers/CMOs Fluent professional English

Especially strong fit if you also have: 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 Knowledge of EU MDR 2017/745, FDA 21 CFR 820/QMSR, ISO 14971 Experience with eQMS platforms (Dot Compliance, Master Control, Veeva Vault) or MES/ERP/PLM environments

Please apply directly if you're interested.

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