Quality Assurance Specialist

ROLE, RESPONSIBILITIES and AUTHORITIES:
· Support in the maintenance of updated quality management system in compliance with applicable regulatory requirements. Implementing quality assurance policies and procedures. Identifying and resolving workflow and process issues. 
· Responsible for executing and maintaining the document control system.
·  Support in the implementation and control of various QMS system processes including customer complaint handling, post market surveillance activities, control of other processes according to need.
·  Responsible for control of training processes of employees on Organizational level.
·  Responsible for correct implementation of the translation review process.Monitoring, inspecting, and proposing measures to correct or improve a company’s system and processes in order to meet established quality standards
QUALIFICATIONS AND EDUCATION REQUIREMENTS:
·  College degree in related science and at least 3 years of relevant professional experience working in quality and/or regulatory affairs under European regulation.
·  Familiar with the requirements for medical devices’ quality management system of ISO 13485 and FDA 21 part 820 QSR, and with European Medical Device Directive/Regulation, standards and guidelines relevant to the field of medical devices.
·  MUST HAVE Excellent personal skills of: 
·  Strong attention to details
·  Problem-solving approach
·  Organizational and planning
·  Work independently and in a team Communication.
PREFERRED SKILLS:
English in very good level, both verbal and writing.
Co-working abilities with other departments