Auditor / провідний аудитор з оцінки відповідності медичних виробів

About the role

We are looking for an Auditor / Lead Auditor to assess the conformity of medical devices with national and international regulations. The successful candidate will lead audit projects, evaluate quality management systems and ensure compliance with relevant standards.

Key responsibilities

• Plan and conduct audits of medical device manufacturers.
• Evaluate quality management systems against ISO 13485 and ISO 9001.
• Analyse technical documentation and verify conformity with medical device technical regulations.
• Prepare audit reports, document findings and manage non‑conformities.
• Recommend corrective actions and follow up on their implementation.
• Interact with manufacturers and support improvement of internal procedures and methodological materials.

Required profile

• Higher education in medicine, pharmacy, biology, chemistry, physics, bio‑engineering, electronics, IT or related fields.
• Experience in medical devices, quality management systems or conformity assessment.
• Knowledge of ISO 13485, ISO 9001, ISO 14971 and medical device technical regulations (preferred).
• Proven audit experience and familiarity with technical documentation.
• English proficiency sufficient for working with standards and technical documents.
• Analytical mindset, attention to detail and willingness to travel for business trips.

Required skills

• ISO 13485
• ISO 9001
• ISO 14971
• Medical device technical regulations
• Audit methodology
• Technical documentation analysis
• English (technical)

What we offer

• Official employment with social guarantees according to Ukrainian labor law.
• Work schedule: Monday‑Thursday 09:00‑17:30, Friday 09:00‑16:30.
• Opportunities for professional training and qualification development.