Senior Qa Quality

SEMA CELIK

Beylikduzu- Istanbul/ TURKEY +90-553-***-**-** **********************@*******.***

https://www.linkedin.com/in/sema-çelik-5844b8152/

Summary

Confident, detail-oriented Senior Quality Assurance Specialist with more than four years of experience establishing in-house quality standards and procedures, ensuring client requirements are accurately executed and monitoring manufacturing processes.

Objective

My primary objective as a Senior QA Specialist is to bring success to the company by ensuring that the products, performance, systems and processes adhere to set standards and requirements. Having been a Senior Quality Assurance Specialist nearly for four years, I have enhanced my abilities in assessing requirements, investigating and setting up standards, performing actual systems testing, determining problems and needs, and resolving quality assurance issues. One of my objectives is to further my expertise in the field of quality assurance, and I am confident I can do this best if I will be a part of a dynamic and competent environment. Education

BACHELOR'S DEGREE 1998-2004 KARADENIZ TECHNICAL UNIVERSITY Faculty of Arts and Sciences Department of Chemistry ANATOLIAN HIGH SCHOOL DATE EARNED IBNI SINA ANATOLIAN HIGH SCHOOL- HATAY Skills & Abilities

· Hands-on experience in managing QA activities * Project management

· Sound knowledge of ISO 13485, ISO 9001 and GMP * Strong decision maker

· Complex problem solver * GMP Trainer

· Good team player * Analytical thinking

· Excellent management skills

· Performed compliance audits and maintained accurate records

· Worked with different government organizations

Communication

· Motivated team player and safety conscious individual with proven ability to locate and interpret product quality specifications and requirements.

Language

· English – Advanced Level

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Experience

HEAD OF DISPOSABLE DIVISION NEPHROCAN MEDIKAL DECEMBER 2021- Still Working

· To be responsible for the management and administration of the production personnel and production department,

· Establishing and supervising the general operation of the processes in the production process and ensuring uninterrupted production in a way that fulfills the production work orders,

· Responsible for the supervision of every stage of production activities,

· Making short, medium and long-term plans for the development of the production department,

· Ensuring that the production process starts and ends at the right time,

· Responsible for the production of products in accordance with quality standards,

· Analyzing machine downtimes and their causes, informing the maintenance team for downtimes, being responsible for following the interventions,

· Responsible for arranging daily and weekly production reports and controlling the reports,

· To be responsible for the extraction of daily production yields and losses and root-cause analysis,

· Supervising the Occupational Health and Safety processes in the work area,

· To be responsible for the preparation of productivity and performance reports of production personnel,

· Responsible for the periodic maintenance and repair of production machines,

· Responsible for the creation and management of productivity, 5S and quality improvement projects. SENIOR QUALITY ASSURANCE SPECIALIST NEPHROCAN MEDIKAL FEBRUARY 2018- DECEMBER 2021

· To carry out Quality Management System studies in accordance with National and International standards and regulations for Class III, Class IIb, Class IIa and Class II medical devices subject to injection and extrusion,

· Preparation of Procedure based on EN ISO 13485 QUALITY MANAGEMENT SYSTEM and ensuring other required documents, such as Instructions and recording documents

· Determining staff training needs, monitoring and monitoring of training processes,

· Collecting records/ datas/ information for quality-based reporting and preparing and publishing quality reports.

· To follow CE technical file preparation and certification processes for Class III, Class IIb, Class IIa, Class II (medical devices in accordance with the MDD 93/ 42/ EEC and EN ISO 13485: 2016, EN ISO 14971:2019), Class I (medical devices in accordance with the 93/42/EEC and EN ISO 14971, EN ISO 13485, EN 60601-1, EN 60601-1-2, EN 60601- 1-6 and EN 62366-1) and Class IM (medical devices in accordance with the MDD 93/ 42/ EEC and EN 60601-2-52, EN ISO 14971, EN ISO 13485, EN 60601-1, EN 60601-1-2, EN 60601- 1-6 and EN 62366-1),

· To follow national and international standards and to make GAP analysis between current and old version of that one, if there is changes in any standard,

· To be part of Risk Management team to make product based risk and risk-benefit analysis accordance with ISO 14971:2019 STANDARD,

· Controlling the customer feedback and complaints processes,

· Information and experience related to Medical Device Directives, MEDDEV 2.1 Scope, field of application, definition MEDDEV 2.2/1 Essential requirements, MEDDEV 2.4/1 Classification of MD and MEDDEV 2.12/2 POST MARKET CLINICAL FOLLOW-UP STUDIES,

· Registration of Medical devices to Ministry of Health System (TITCK and UTS system),

· To make product entries to the tracking system,

· Provide support for hosting external/ internal audits

· Conducting negotiations with external auditors' organizations and authorities in CE and ISO certifications,

· To carry out the sterilization validation and clean room validation studies.

· Act as a QA mentor to personnel and provide training where required Page 3

PROJECT DEVELOPMENT SPECIALIST TEK-DEV TECHNOLOGICAL RESEARCH CENTER DECEMBER 2016- FEBRUARY 2018

· EU, TUBITAK and KOSGEB PROJECT MANAGEMENT

QUALITY ASSURANCE SPECIALIST METAL KIMYA OCTOBER 2015- NOVEMBER 2016

· To carry out ISO 9001 Quality Management System studies in accordance with National and International standards and regulations

· Implementation and follow-up of production processes of glass enamels and chemicals, quality control and compliance with ISO 9001 standards, archiving, documentation.

· Preparation of Procedure, Instructions and other relevant documents related to ISO 9001 QUALITY MANAGEMENT SYSTEM

SALES AND MARKETING MANAGER MSM DIŞ TIC ITH. IHR. LTD. ŞTI. SEPTEMBER 2012- SEPTEMBER 2015

· Management of the marketing and sale of carton-made party materials in Turkey CHEMISTRY TEACHER SINAV DERGISI DERSHANELERI SEPTEMBER 2006- JULY 2012

· To be ready for teacher recruitment. Organizing and controlling the compliance of the branch courses with the MEB curricula in terms of content. Teacher-student relationship to follow up. Project development to increase the student's success and motivation in the courses.

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