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 tech

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