Seher Kalender

Seher Kalender Email and Phone Number

İstanbul, İstanbul, TR
Seher Kalender's Location
Istanbul, Istanbul, Türkiye, Turkey
About Seher Kalender

Solid career path started with quality assurance domain with medical imaging modalities required high performance with versatility. Motivated and hardworking professional with great enthusiasm to provide excellent internal and external customer service. Strong analysis skills with the ability to engage highly motivated to maintain a solid work history for increasing authority and responsibility. Well-organized with a track record that demonstrates self-motivation, perseverance to fulfill both personal and corporate goals.

Seher Kalender's Current Company Details
SBG Conformity Assessment A.Ş. (former Standart BM Trada A.Ş.)

Sbg Conformity Assessment A.Ş. (Former Standart Bm Trada A.Ş.)

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Certification Coordinator
İstanbul, İstanbul, TR
Website:
exova.com.tr
Employees:
14
Seher Kalender Work Experience Details
  • Sbg Conformity Assessment A.Ş. (Former Standart Bm Trada A.Ş.)
    Certification Coordinator
    Sbg Conformity Assessment A.Ş. (Former Standart Bm Trada A.Ş.)
    İstanbul, İstanbul, Tr
  • Neoauvra
    Quality Assurance Supervisor
    Neoauvra May 2022 - Present
    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.
  • General Survey Inspection Co
    Quality Assurance Supervisor
    General Survey Inspection Co Aug 2019 - May 2022
    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
  • Emis Kalibrasyon Ve Olcum Sistemleri Hiz. San. Tic. Ltd. Sti.
    Quality Manager & Electrical Laboratory Supervisor
    Emis Kalibrasyon Ve Olcum Sistemleri Hiz. San. Tic. Ltd. Sti. Dec 2016 - Jul 2019
     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)
  • Netes Engineering
    Calibration Engineer
    Netes Engineering Mar 2012 - Dec 2016
    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.
  • Kanit Radiology Equipments
    Product Specialist
    Kanit Radiology Equipments Apr 2010 - May 2011
    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

Seher Kalender Skills

Calibration Medical Physics Iso 13485 Iso 9001 Iso 17025 Ce Marking Quality Certification Quality Control Quality Assurance Quality Management Regulatory Affairs Documentation Electronics Product Management Rf Physics Medical Imaging Radiography Measurements Quality System Test Equipment Radiology Trading Nuclear Medicine Anatomic Pathology Brachytherapy Anatomy Time Management Microsoft Office Inquisite Problem Solving Analysis Research Sensors Biomedical Engineering Oscilloscope Medical Devices

Seher Kalender Education Details

Frequently Asked Questions about Seher Kalender

What company does Seher Kalender work for?

Seher Kalender works for Sbg Conformity Assessment A.ş. (Former Standart Bm Trada A.ş.)

What is Seher Kalender's role at the current company?

Seher Kalender's current role is Certification Coordinator.

What schools did Seher Kalender attend?

Seher Kalender attended Hacettepe Üniversitesi, İstanbul Ticaret Üniversitesi, Muzaffer Çil Anadolu Lisesi.

What are some of Seher Kalender's interests?

Seher Kalender has interest in Skating, Travelling, Technology, Nlp, Reading, Photography, Fitness, Playing Guitar, Swimming, Movies.

What skills is Seher Kalender known for?

Seher Kalender has skills like Calibration, Medical Physics, Iso 13485, Iso 9001, Iso 17025, Ce Marking, Quality Certification, Quality Control, Quality Assurance, Quality Management, Regulatory Affairs, Documentation.

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