Açıklama:
GENEL NİTELİKLER VE İŞ TANIMI
GENEL NİTELİKLER VE İŞ TANIMI
Qualifications
1 - 3 years related experience in the medical industry
Knowledge of ISO 13485:2016 and MDR requirements
Excellent communication skills, both written and verbal
Problem solving skills
Able to work well within a team
Highly organized with strong attention to detail
Self motivated
Ability to prioritize the workload and effective time management
Able to review, trend, analyze and report data using databases and/or Excel
Good command of English,
Male candidates must have completed their military service
Job Descrıptıon
Performs the preparation and coordination of technical file for CE and FDA
Performs the preparation and coordination of documents for registration
Support the review, update, and implementation of procedures to ensure compliance to regulations and standards.
Performs the preparation and coordination of internal and external audits
Providing Quality support to Operation daily activities.
Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
Assists with maintaining established departmental policies and procedures, objectives, and quality improvement, safety, and environmental standards
Performs the preparation and coordination of technical file for CE and FDA