Product Quality Specialist

Bahadir Tıbbi Aletler A.S.

Job Description

•  Providing the necessary tests for the related regulations and to prepare documentation in the relevant language.

•  Dealing with the legal regulations and obligations required for the sale of these products.

•  Managing, reporting and following up the complaints management and PMS (Post Market Surveillance) processes.

•  Providing necessary translations about regulations.

•  Coordinate and conduct external audits of related regulations.

•  Finding the source of quality problems and to work in coordination with the related units to solve the problems.

•  Making projects together with teams to be formed from other units within the framework of TQM.

•  Providing work for the development of production methods in the company.

•  Recommendations for ensuring that production processes, working environment and personnel to comply with ISO 13485, MDD / MDR, FDA requirements.

•  Support and strengthen the quality department in all issues regarding Quality and Regulatory.

•  Managing and following up all these activities in parallel with the information system processes, to review and evaluate regularly.

Qualifications

Required skills:

•   Graduate from engineering faculty of universities

•   Fluency in both written and spoken English (for preparing documents, translating and oral-written communicating)

•   Proficiency in operating MS Office (Word, Excel ve PowerPoint)

•   Willing to research about medical device products

•   Excellent organizational skills

•   No travel restriction

•  No military obligation for male candidates

Preferred skills:

•   Familiar with ISO 9001 and ISO 13485

•   Auditing experience to Quality Systems 

•   Experience with handling FDA audits for approval of medical device products