Quality Assurance Engineer İş İlanı
İşveren Hakkında
QUALIFICATIONS AND JOB DESCRIPTION
ESSENTIALS
We are looking for a teammate for our Medical Device company located in Izmir, Cigli AOSB;
· Detail-oriented, cautious, and responsible,
· Ability to communicate confidently and solve problems effectively,
· Proven work experience in Quality Assurance on Medical Devices (min. 2 years),
· Experience in writing clear, concise, and comprehensive plans, instructions and procedures,
· BS/MS degree with an applied thesis on Biotechnology, Biomedical Engineering or Bioengineering,
· Vast knowledge on ISO 13485:2016 Medical Device Quality Systems and (EU) 2017/745 Medical Device Regulation,
· Project management skills as; critical thinking, task management, time management, collaboration,
· Completed military service (for male candidates),
· Advanced in English.
JOB DESCRIPTION
· Devise and implement research and testing protocols for key quality metrics on each project under the engineer’s purview,
· Analyze quality assurance test data to determine whether or not current quality testing measures yield appropriate results,
· Coordinate testing and production to ensure scheduling unity across the company,
· Identifying deficiencies and suggesting solutions to the problems,
· Collaborate with the Product Development team to ensure consistent project execution,
· Identify quality assurance process bottleneck and suggest actions for improvement,
· Prepare and present reports and metrics to the Management,
· Estimate, prioritize, plan and coordinate project subtasks,
· Liaise with internal teams and external teams to identify Quality Management System requirements,
· Investigate the causes of non-conformities and train personnel to correct existing and prevent future problems,
· Stay up-to-date with international standards and regulations,
· Controlling the suitability of the medical devices under the Quality Management System pre-release to the market,
· Organizing and keeping the Technical Documentation and the EU declaration of conformity up to date,
· Compliance with Post-Market Surveillance obligations,
· Detailed investigation of adverse events and implementation of actions on procedures and regulation of field safety corrective actions for Vigilance activities,
· Planning and organizing R&D projects for the certification of newly developed medical devices,
· Organizing necessary external contacts throughout the product life cycle,
NOTE: Applications of candidates who do not prepare an English cover letter and do not meet the criteria above will not be considered. You are kindly requested to submit your applications accordingly.
