Quality, Laboratory and Regulatory Manager

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, Laboratory and Regulatory Manager " with following qualifications.

QUALIFICATIONS

·         BS/BA in a Chemical Engineering, Biomedical Engineering, Bioengineering or Biology departments of universities; MBA is preferred

·         At least 10 years of experience in Quality System with at least 5 years in the Medical Device industry

·         Having very good knowledge and certifications such as ISO 9001, ISO 13485, ISO 27001, ISO 14971, MDD-MDR (Medical Device Regulation) standards

·         Having Internal Auditor certificate

·         Having very well quality awareness and knowledge

·         Team management experience

·         Very good level of English (at a level to prepare documents, translate and communicate in written and oral)

·         Clear verbal and written communication skills, and ability to effectively communicate with internal and external personnel

·         Proficient in MS Office applications

·         Completed military service for male candidates

JOB DESCRIPTION

·         Leading the Quality Assurance, MDR Project and Laboratory processes

·         Preparation of MRR (Management Review Reports) and Risk Management Report and to submit Upper Management to asses the effectiveness of quality system.

·         Implementation and sustainability of Bıçakcılar standard operational procedures by using QDMS documentation programme

·         Performing internal and external audits / Corrective & Preventive actions (CAPA) follow-up

·         Supplier management and evaluation activities

·         Coordinating product complaints-vigilance handling and Health Authority responses

·         Effectiveness of ISO 14971 Risk Management and FMEA activities

·         Monitoring all change control activities within organisation

·         Project management for MDR transition

·         Follow up actual standards, directives, regulations and guidence documens to comply with legal requirements

·         Coordination for preparation of Technical Files because of CE audits and new product applications

·         In order to develop competencies of employees by giving periodic trainings

·         Coordination of validation activities (process, sterilisation, cleanroom, packaging etc)

·         Implementation of BIÇAKCILAR Accredited Test Laboratory in 2005 and managing in accordance with ISO 17025 norms and GLP rules

·         Coordination to develop new test methods in Chemical and Microbiology Laboratories.

·         Ensure to increase the revenue of accredited test Laboratory by preparing business plans and sales activities