Role: Senior Quality Engineer (Production)
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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 xcskxlj 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
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