Experteer Overview
In this role you ensure production, microfabrication and final quality control for medical devices are performed under controlled, compliant, and traceable conditions.

You’ll support Quality u0026amp; Regulatory through production controls, calibration, environmental monitoring, and documentation readiness for internal and outsourced manufacturing.

You will influence release decisions and drive continuous improvement in a fast-moving, high-stakes environment.

This is an office-based position in Barcelona with occasional needs at Bellaterra, offering meaningful impact in patient care and cutting-edge technology.

Compensaciones / Beneficios
• Monitor production and microfabrication for compliance with SOPs, WINs, specs, control plans, PFMEAs and QMS procedures
• Support production controls including line clearance, contamination control, traceability and in-process/final quality controls
• Oversee facility and cleanroom quality including access controls, gowning, environmental monitoring and escalation of out-of-limit conditions
• Manage equipment quality activities (registration, labeling, calibration, maintenance, IQ/OQ/PQ, deviations)
• Assist process and test method validation (plans, protocols, deviations, reports, evidence)
• Review records and DHR-like evidence to confirm completeness before lot disposition or QA/PRRC release
• Investigate nonconformities, support CAPA and continuous improvement
• Support supplier/CMO quality oversight and change notifications
• Maintain quality KPIs and production monitoring inputs (nonconformities, yield, calibration, environmental excursions, CAPA)




• Train staff on GDP, GMP-like practices, cleanroom behavior, documentation and quality expectations
• Support internal and external audits and FDA/EU-readiness activities for production and infrastructure

Responsabilidades
• Bachelor's degree in a related technical field
• 2–3 years in a regulated manufacturing environment; medical device experience preferred
• Working knowledge of ISO 13485 for production, infrastructure, monitoring and measurement equipment, process validation, traceability, nonconforming product and CAPA
• Experience with production controls, inspection and batch records, DMR/DHR documentation or equivalent
• Experience supporting equipment calibration, maintenance, qualification, verification or validation
• Strong attention to detail and ability to review technical documentation, criteria, tests, deviations and quality reports
• Fluent professional English; ability to write controlled documents and quality records clearly
• Ownership of documentation quality, pragmatic risk-based decision making
• Ability to work hands-on with cross-functional teams and escalate when needed
• Structured problem-solving mindset for deviations and process variability
• Comfort with ambiguity and continuous improvement mindset
• Knowledge of GDP, GMP-like practices and cleanroom requirements (nice to have)

Requisitos principales
• Private Health Insurance
• Training bonus for professional development (Udemy)
• 23 vacation days per year
• Christmas week off
• Internal versátil compensation scheme
• Competitive salary

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