Quality Management Engineer

RESPONSE ORTHO TEKNOLOJİK ÜRETİM A.Ş.

JOB DESCRIPTION

*  Supports the review, update and implementation of procedures to ensure compliance with regulations and standards,

*  Takes part in the preparation of technical files for certification activities,

*  Performs the necessary procedures for product registration,

*  Takes part in internal and external audit processes,

*  Supports the daily operations of the Quality Management Department,

*  Cooperates with other departments to ensure that the quality standards are in place,

*  Participates in maintain continuous improvement towards policies, objectives and quality system.

GENERAL QUALIFICATIONS

*  Graduated from related engineering departments of universities,

*  Have at least 2 years of active experience in ISO 13485:2016 and EU medical device requirements,

*  Will take part in product (93/42/EEC MDD, 2017/745 MDR, FDA) and quality management system (ISO 13485:2016) certification processes,

*  Preferably with experience in software requirements as a medical device (ISO and FDA)

*  Preferably with experience in sterile packaged products,

*  Preferably with QDMS or similar quality management system software experience,

*  Able to communicate in written and verbal English,

*  Have strong interpersonal communication skills,

*  Having problem solving skills,

*  Collaborate effectively with others to achieve team goals and expectations.