Quality Assurance Specialist

Quality Assurance Consultant - EU MDR

Location: 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 Responsibilities

• Lead 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
• Su...