Quality Assurance Specialist - Barcelona
hace 1 día
Descripción del trabajo
Quality Assurance Consultant - EU MDRLocation:
Barcelona, Spain
Length: 12 months contract (freelance)
Hours: 40 hours/week (hybrid)
Start Date:
ASAP
Role Overview
As a key member of the Quality & Regulatory Operations function, you will support EU MDR‑driven quality initiatives, ensuring that key QMS processes, documentation, and operational systems meet regulatory expectations.
This is a hands‑on QA consulting role suited to professionals experienced in compliance remediation, documentation control, and audit readiness within medical devices.
Key ResponsibilitiesLead and support quality system activities required for EU MDR alignment across manufacturing and design operations
Review, update, and remediate controlled documents including SOPs, work instructions, technical files, and QMS records
Ensure documentation quality, traceability, and consistency with ISO 13485, EU MDR, and 21 CFR 820
Support internal audit preparation, NB audit readiness, and corrective actions following audit findings
Participate in risk management updates (ISO 14971), design history file reviews, and quality planning
Partner with Engineering and Operations to address quality gaps, CAPAs, deviations, and change control impacts
Provide QA oversight on process changes, equipment qualifications, and validation deliverables and continuous improvement.
Requirements
3+ years' experience in Quality Assurance within Medical Devices, Pharma, or related regulated industry
Strong working knowledge of EU MDR, ISO 13485, and 21 CFR 820
Experience with QMS documentation, audit preparation, and compliance remediation
Familiarity with risk management, CAPA processes, change control, and technical documentation
Ability to work in fast‑paced, audit‑driven environments and manage multiple priorities
Experience with device manufacturing, cleanroom operations, or validation activities is an advantage
Fluency in Spanish and English
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