Senior Quality Engineer

Barrington James; Barcelona; Híbrido; EUR 70.000 - 95.000; Jornada completa

Descripción de la vacante

Barrington James is representing a fast-growing medical technology company in the Barcelona area. We are seeking a Senior Quality Engineer (Production) to own production quality across manufacturing and microfabrication, partnering with external vendors to keep processes controlled and devices safe.

This is a hands-on, individual contributor role (no management) focused on SOPs, control plans, PFMEAs, IQ/OQ/PQ, calibration, CAPA, and internal/external audits.

Formación

• Bachelor's degree in a technical field as listed in the job ad.
• 5+ years of quality engineering in regulated medical device manufacturing.
• Hands-on ownership of production quality activities beyond support.
• Experience with validation, qualification and process controls.
• Knowledge of ISO 13485, traceability, CAPA and nonconforming product.

Responsabilidades

• Own production quality controls across manufacturing and microfabrication, including SOPs and control plans.
• Lead process and test method validation and review protocols and reports.
• Oversee equipment qualification and calibration, with IQ/OQ/PQ reviews.
• Manage cleanroom quality, environmental monitoring and out-of-limit escalation.
• Lead nonconformity investigations and CAPA verification.
• Oversee supplier/CMO quality, deviations, change notifications, and manufacturing records.
• Provide coaching on production quality and cleanroom practices to staff.
• Support internal and external audits and FDA/ notified body readiness.

Conocimientos

Quality engineering

Process validation

Equipment qualification

CAPA investigations

Cross-functional collaboration

Auditing readiness

Educación

Bachelor's degree in Biomedical Engineering, Industrial Engineering, Materials Science, Micro/Nanotechnology, Life Sciences or related field

Herramientas

ISO 13485

eQMS platforms (Dot Compliance, Master Control, Veeva Vault)

MES/ERP/PLM environments

Descripción del empleo

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