Kalite Güvence Sorumlusu

Disera Tıbbi Malz. Lojistik San. ve Tic. A.Ş.

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