Responsibilities:
- planning and conducting audits of medical device manufacturers;
- assessment of quality management systems in accordance with the requirements of ISO 13485 and ISO 9001;
- analysis of technical documentation and assessment of conformity of medical devices with the requirements of technical regulations;
- preparation of reports, execution and documentation of audit results;
- analysis of nonconformities and corrective actions of manufacturers;
- interaction with manufacturers;
- participation in improving internal procedures and methodological materials.
Candidate requirements:
- higher education in the fields of medicine, pharmacy, biology, chemistry, physics, bioengineering, electronics, IT or related specialties;
- experience in the field of medical devices, quality management systems, or conformity assessment;
- knowledge of ISO 13485, ISO 9001, ISO 14971 and technical regulations on medical devices will be an advantage;
- experience in conducting audits and/or working with technical documentation;
- English proficiency sufficient for working with standards and technical documentation;
- analytical thinking and attention to detail;
- readiness for business trips.
We offer:
- official employment;
- social guarantees in accordance with the labor legislation of Ukraine;
- working hours: Monday–Thursday – from 09:00 to 17:30, Friday – from 09:00 to 16:30;
- opportunities for professional training and advanced qualification.
If you do not meet the above criteria but would like to join the Center's team of specialists, send us your résumé, indicating the vacancy that interests you. Your résumé will be added to the personnel reserve. When a suitable vacancy appears, we will offer it to you for consideration.
By sending your CV, you consent to the processing of personal data in accordance with the Law of Ukraine “On Personal Data Protection”.
We are grateful to male and female veterans for their service and are open to employing them at the State Expert Center of the Ministry of Health of Ukraine.
