Quality Systems Specialist

About the role

The Quality Systems Specialist will support all processes related to the Quality Management System (QMS) at Biotech Europe Meditech. The role ensures compliance with internal quality standards, FDA regulations and international regulatory requirements while helping the company meet its business objectives.

Key responsibilities

• Manage product complaints, CAPA, NCRs and generate KPI reports for continuous improvement.
• Support validation activities, risk‑assessment reviews and ensure deviations are documented and addressed.
• Coordinate environmental monitoring, in‑process bioburden testing and maintain up‑to‑date environmental metrics.
• Assist Regulatory Affairs with international submissions, query responses and maintenance of technical master files.
• Prepare change notifications, validation protocols, reports and provide manufacturing support for new product introductions and transfers.
• Develop internal customer service relationships to ensure teams have the data and resources needed for effective performance.

Required profile

• University or technical college education.
• Previous experience in a high‑volume production environment, preferably in biotech or medical‑device manufacturing.
• Strong computer proficiency for change‑control and documentation management.
• Familiarity with ISO 13485 and 21 CFR 820 quality systems.
• Excellent communication, attention to detail and proven problem‑solving abilities.

Required skills

• ISO 13485
• 21 CFR 820
• CAPA management
• NCR handling
• Validation and re‑validation processes
• Risk assessment methodology
• Environmental monitoring techniques
• Regulatory submission preparation
• Change‑control management