Quality System Specialist – Medical Devices

About the role

The Quality System Specialist will lead the harmonisation and continuous improvement of the Quality Management System for a global MedTech manufacturer. Based in Lyon, you will act as the primary point of contact for all quality‑related queries and support both internal teams and external partners.

Key responsibilities

• Manage review meetings and processes for non‑conformances, CAPAs, customer complaints and deviations.
• Own and maintain Quality System documentation and records.
• Support notified body audits and conduct internal audits.
• Lead supplier audits and performance reviews in line with project timelines.
• Provide guidance on quality and regulatory affairs to internal and external stakeholders.
• Collaborate with the regulatory department on day‑to‑day regulatory activities.
• Travel up to 25 % across European sites to ensure consistent implementation.

Required profile

• Minimum 3 years of experience in quality systems for medical devices.
• Hands‑on experience with ISO 13485 and ISO 27001.
• Background in small to medium‑sized companies.
• Fluent English communication skills.

Required skills

• ISO 13485
• ISO 27001