Keywords
Skills
- Perfect computer proficiency
- ISO 13485:2016 ; MDD 93/42/EEC; ISO 9001:2015; ISO EN 13795;
- Performance: on laboratory tests on non wovens.
- Leading quality department (7-9 employees) : organization of control along production and packing stage, testing of products in the process of manufacturing by internal laboratory. Issueing quality certificates for dispatched product, confirm that it fulfils client and regulatory requirements.
- Conducting internal audits. Representation of the company during external audits of authorized bodies, clients.
- Corrective / preventive action management (CAPAs), complaints to suppliers, complaint s from clients.
- Validation of processes
- Organization of calibration / calibration of control and measuring equipment and measuring instruments necessary for the functioning of the Quality Management System
- Leading incoming inspection of raw materials, rational decision taking related .
Providing requirements for microbiological monitoring of production lines and product - Management of sterile products. Vigillance responsible
- Constant improvement of QMS. Develop new internal procedures, or revision of present to comply with recent requirements and interests.
Project history
FAPOMED UKRAINE, LLC. Manufacturing of disposable medical devices.
July 2012 - September 2014 - Quality Controller
September 2014 - August 2018- Head of the Quality Department
July 2012 - September 2014 - Quality Controller
September 2014 - August 2018- Head of the Quality Department
Local Availability
Only available in these countries:
Ukraine
I am available to travel all over the world, as soon as traveling takes not more than 20% of work time.
Hours flexibility.
I am ready to agree time of work with each hiring company.
Hours flexibility.
I am ready to agree time of work with each hiring company.
