About the Role

We are seeking a Quality Specialist to support the implementation and maintenance of our Quality Management System, ensuring full compliance with ISO 13485, ISO 14971, and applicable medical device standards.

Responsibilities

• • Maintain QMS documentation and internal procedures.

  • Support audits, CAPA processes, and risk management activities.

  • Monitor supplier quality and incoming inspection processes.

  • Contribute to product and SaMD quality documentation.

Requirements

• • Knowledge of ISO 13485 and QMS concepts.

  • Strong analytical and documentation skills.

  • Experience in regulated industries (medical, pharma, biotech, or similar).

  • Ability to work cross-functionally with regulatory and technical teams.

What We Offer

• Opportunity to grow within an expanding global medtech company.

• Real exposure to international regulatory strategies and digital health projects.

• Training in regulatory affairs, quality systems, and SaMD regulations.

• Flexible work environment and career development path.

→ Candidates should submit their CV and a short motivation message through the application form.