Quality Engineer

Quality Engineer

A growing MedTech company developing innovative healthcare solutions is looking for a Quality Engineer to strengthen its Quality team as it scales its technology platform and expands into new clinical applications.

This role will focus on ensuring software quality, regulatory compliance, and risk management across the product lifecycle, working closely with engineering teams to maintain and improve quality processes within a regulated environment.

Key Responsibilities

• Maintain and improve the ISO 13485-compliant Quality Management System

• Own and manage product risk management processes (ISO 14971)

• Oversee quality aspects of software development and product release processes (development, update, automation & execution)

• Manage CAPA, non-conformities, error monitoring, and escalation processes

• Support product development activities, including testing, documentation, and regulatory technical files

• Focus on QMS software validation

Your Profile

• 3+ years of experience as a Quality Engineer within MedTech or another regulated industry

• Strong knowledge of ISO 13485, ISO 14971, and ISO 62304

• Experience supporting software development quality processes

• Bachelor’s degree in Engineering or a related technical field

• Strong communication skills in English and ability to work in cross-functional teams