Senior Quality Engineer, Medical Devices – Production

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

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.