QUALIFICATIONS AND 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.
• 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
• Familiar with ISO 9001 and ISO 13485
• Auditing experience to Quality Systems
• Experience with handling FDA audits for approval of medical device products