Quality Control Engineer

Bıçakcılar Tıbbi Cihazlar San. ve Tic. A.Ş.

Bıçakcılar is a global biomedical technology company headquartered in Istanbul, Turkey that designs, develops solutions and produces medical disposables, therapies and medical equipment to serve mostly the surgical space through R&D, Innovation, Laboratory Services and expert production with the continuous target for the safest, accessible medical devices built on saving human life.

Turkey's leading manufacturer of medical devices and disposable medical devices and brand of our company to serve in our factory in Esenyurt, we are looking for an "QUALITY CONTROL ENGINEER" with following qualifications.

General Tasks & Responsibilities:

Manage and perform process validation activities and annual reviews for processes

Routine sterilisation process, and DHR follow-up (report, review & approval)

Implementation and coordination of new/revised standarts and related procedures

Supporting change management activities and process FMEA reviews.

Prepare and report metrics at QMS reviews

Manage and report stability testing activities

Perform other duties as assinged by quality management such as CAPAs

Work closely with the development and QA team

Keep records of quality reports, istatistical reviews and relevant documentation

Skills & Experience

Strong written, oral and interpersonnal skills in English

University degree in engineering or other related technical fields

Min 2 years’ experience in QC Testing, process validation.

Knowledge of ISO 13485, ISO 9001, ISO 11135 standarts

Strong analytical and problem solving skills&excellent interpersonal and communication skills& a team player

Experienced using statistical methods and risk