Quality Engineer

Quality Engineer A growing Med Tech 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 Med Tech 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

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