Quality Assurance Consultant

Quality Assurance Consultant - Medical Equipment Manufacturing (Berlin 🇩🇪)

An opportunity to support a leading medical‑device manufacturer in Berlin on a high‑impact Quality Assurance assignment. This project focuses on strengthening compliance, product reliability, and documentation excellence across a portfolio of Class III cardiovascular implantable technologies, including pacemakers, ICDs, cardiac leads, and minimally invasive vascular systems.

📍 Location: Berlin (Hybrid)
📅 Duration: 12‑month contract
🚀 Start: ASAP

Your Role

• Ensure quality and compliance activities across the lifecycle of active implantable devices, in alignment with ISO 13485, EU MDR, and global regulatory expectations for Class III cardiac technologies.
• Support audit readiness and maintain high‑quality technical documentation, including DHF, DMR, and risk‑based files for implantable electronics and cardiac leads.
• Oversee quality processes related to biocompatible materials, implantable assemblies, and sterile packaging, ensuring robust manufacturing controls and post‑market surveillance.
• Collaborate with R&D, Manufacturing, Regulatory, and Supplier Quality teams to uphold GMP standards, strengthen CAPA systems, and maintain an inspection‑ready QMS.

Key Requirements

✅ Proven experience in Quality Assurance within medical‑device manufacturing, ideally with active implantable or cardiovascular technologies.
✅ Strong understanding of ISO 13485, EU MDR, and familiarity with FDA 21 CFR Part 820.
✅ Knowledge of implantable pulse generators, ICD systems, cardiac leads, and associated sterilisation and assembly controls.
✅ Skilled in risk management (ISO 14971), technical documentation, and quality oversight for high‑reliability, safety‑critical devices.
✅ Detail‑oriented, proactive, and effective in cross‑functional engineering environments.

📤 Interested?
Send your CV and availability!