Quality Systems Specialist (Medtech)

TL;DR

Quality Systems Specialist (Medtech): Building and maintaining a Healthcare Quality Management System for medical software products with an accent on regulatory compliance and ISO standards. Focus on coordinating external audits, ensuring SaMD compliance for EU/US markets, and improving systemic quality processes.

Location: Romania, Poland, Cyprus, Latvia, Bulgaria. Remote options available for candidates in Bulgaria and Poland.

Company

Global IT services provider specializing in software engineering and digital transformation for various industries, including healthcare.

What you will do

• Maintain and support the Healthcare Quality Management System (QMS) and its certification activities.
• Coordinate and participate in external and internal audits, including evidence collection and reporting.
• Provide quality guidance to medical software projects across the full development lifecycle.
• Track and coordinate corrective and preventive actions (CAPA).
• Collaborate with engineering, legal, and compliance teams on regulatory requirements.
• Conduct supplier evaluations and deliver internal quality awareness workshops.

Requirements

• At least 3 years of experience working with medical device quality systems.
• Practical experience with ISO 13485 and ISO 14971.
• Degree in engineering, medical technology, life sciences, or a comparable field.
• Experience with structured documentation and regulated software processes.
• Professional working proficiency in English.

Nice to have

• Experience conducting or participating in audits.
• Knowledge of IEC 62304 or other medical software lifecycle standards.
• Understanding of Agile software development practices.
• Familiarity with EU or US medical device regulatory frameworks.

Culture & Benefits

• Health insurance for employees and their families.
• Vacation and sick pay provided according to national laws.
• Time off for state holidays regardless of the client's schedule.
• Support for IT certifications and access to top-tier learning platforms.
• Corporate events and a supportive, flexible work environment.