Seher Kalender Email & Phone Number

İstanbul, İstanbul, Tr

İstanbul, Türkiye

 To ensure the effective management of ISO 9001, ISO 13485, ISO 62304, ISO 27001, GCP quality management system, FDA applications (21CFR820) and relevant standards for software as a medical device (IEC 62304), including the implementation of product risk management as outlined in ISO 14971. Creating and updating the quality management system documentation, Ensuring the follow-up of quality management targets, Ensuring up-to-date risk analysis (FMEA) Maintaining continuous improvement activities, Meticulous planning and execution of internal audits, Ensuring communication with notified bodies, Following and implementing the revisions of national and international standards, regulations and legislation, Creating quality management awareness throughout the company, Follow-up of CAPAs, customer/employee/supplier feedback. Performing root cause analysis. Planning and follow-up of MRM meetings, Performing supplier audits, Follow-up of product certification studies, Representing the organization in audits.

İstanbul

 To ensure the effective management of ISO 9001, ISO 17020, ISO 17025, ISO 17065 quality management system applications, Managing the activities in order to ensure compliance with the necessary conditions for the continuation of GAFTA / FOSFA memberships, Creating and updating the quality management system documentation, Ensuring the follow-up of quality management targets, Maintaining continuous improvement activities, Meticulous planning and execution of internal audits, Ensuring communication with notified bodies, TURKAK, GAFTA / FOSFA and relevant ministries, Following and implementing the revisions of national and international standards, regulations and legislation, Planning and follow-up of trainings, Follow-up of interlaboratory comparisons, Organizing the Impartiality Committee meetings, Creating quality management awareness throughout the company, Follow-up of CAPAs, customer/employee/supplier feedback. Performing root cause analysis. Planning and follow-up of MRM meetings, Representing the organization in audits. Proactively maintaining high level of customer satisfaction by executing ISO 10002

 To ensure the effective management of the implementations of the ISO 17025 Quality Management System, Creating and updating the quality management system documentation, Ensuring the follow-up of quality management targets, Maintaining continuous improvement activities, Meticulous planning and execution of internal audits, Ensuring communication with TÜRKAK, Following and implementing the revisions of national and international standards, regulations and legislation, Creating quality management awareness throughout the company, Follow-up of CAPAs, customer/employee/supplier feedback. Performing root cause analysis Planning and follow-up of MRM meetings, Performing supplier audits, Planning and follow-up of trainings, Follow-up of interlaboratory comparisons, Monitoring and realizing the calibration / intermediate control / maintenance plan, Approval of certificates, Providing calibration, metrology and measurement uncertainty trainings to customers, Organizing and monitoring the work flow of field personnel, Representing the organization in audits. Attending audits on behalf of Kalitest Certification as Technical Specialist. (ISO 9001 and ISO 13485 audits)

Istanbul, Turkey

 Report to Laboratory Manager, maintaining daily calibration routines of vast array of electrical instruments including but not limited to RF signal generators and power sensors, spectrum analyzers, frequency counters, function generators, power quality analyzers, AC/DC power supplies, insulation, earth, leakage current testers, network cable analyzers, high voltage probes & test devices, current probes, multi-meters, oscilloscopes, mobile test devices, tachometers. Flawlessly perform complex calculations of calibration results to validate equipment in accordance to related standard. Meticulously prepare official calibration result papers as specialist on behalf of authorized laboratory. Listen to customer voice and react proactively to sustain good relationship and ensure complete customer satisfaction.  Periodically follow regulations to quickly adapt requirements and update internal stakeholders. Actively determine and attend courses and trainings which will likely to be necessary to maintain ongoing processes as a Calibration Specialist. Visiting premium customers for performing on-site calibration.

Turkey

 Served comprehensive sales and pre sales support as Product Specialist for various product groups including general x-ray, interventional x-ray, digital x-ray and PACS & RIS from several international vendors.  Administered side role as Quality Management for 6 months and completed successfully acquisition of conformance with ISO 9001, ISO 13485 and medical device directives to obtain CE marking for locally produced digital x-ray modalities in spite of understaffed structure of the mission. Utilized an extensive product portfolio knowledge base to create the best possible solutions according to needs. Actively engaged in tender management procedures in sales activities to ensure optimal business success. Extensively evaluated a variety of complex tender specifications for making “go” and “no go” decisions. Proactively contacted clients and prospects daily by phone or in person to identify additional client needs and strengthen client relationships. Fully supported the team sales process by acting upon or referring identified client needs to other lines of business. Collaborated closely with the project management, account management and application specialist teams to promote and demonstrate product portfolio. Meticulously analyzed the competition to support well designed product positioning for the specific region

Physics Engineering

Master'S Degree, Medical Physics

Education record