Experience implementing corporate policies, procedures and structures used to ensure that appropriate standards of professional practice are maintained.
Preparation and implementation of QMS ISO 13485:2016 requirements.
Handling the products batch file.
Handling and completion of CAPA requested due to self -inspection, management, complaints, internal audit and external audit as GMP, CE etc.
Implementation risk assessment approach for all company process.
Registration for new product and prepare registration file at EDA or CE certificate.
Aware by regulation (EU) 2017/745 of the European parliament and of the council of 5 Aprill 2017 (MDR)
Education: Science, Engineering, pharmacist, Medicine faculty.Should has at least 5 years' experience in the field of medical supplies industry.Training: ISO 13845, CE requirement and internal auditor.