Meryem Kizilkaya
Eindhoven,NB
Summary
A seasoned Quality Assurance and Regulatory Affairs professional, I excel in e-QMS and leadership, driving quality excellence and ensuring compliance with regulatory standards. Skilled in coordinating CAPA and enhancing product reliability, my collaborative approach and results-oriented mindset have significantly contributed to quality improvements and operational efficiency.
Overview
5
5
years of professional experience
1
1
Certification
Work History
Quality Officer
Philips Medical Systems
06.2024 - Current
- Ensuring product quality, while maintaining full compliancy and driving manufacturing excellence.
- Timely releases of products with high quality and outstanding reliability.
- Collaborating with a team of quality engineers, reject handlers and manufacturing engineers.
- Supporting with change management to manufacturing process or controls.
- Charing Material Review Board (MRB) meetings.
- Analysis of defects for determining dispositions of nonconformances - NC/QN Management Process.
- Supporting supplier quality with investigations
Quality Assurance Officer
Reboocon Bionics B.V.
09.2022 - 06.2024
- Maintenance of full Quality Management System (eQMS) for Class-IIa MD, ensuring compliance with relevant regulatory standards (e.g., ISO 13485, MDR 2017/745, ISO 14971, IEC 60601-1, IEC 61340-5-1).
- Acting like an RA Specialist, maintaining Technical Documentation according to the regulations, preparing and managing Compliance Update Reports.
- CAPA and nonconformity Coordinator. This includes processing the various phases of the CAPA and Improvement process.
- Coordination of all quality-related communication internally and externally.
- Fulfilling the annual Quality Management and Regulatory Assurance objectives.
- Participate in external audits conducted by regulatory authorities and internal audits, ensuring timely preparation and addressing audit findings.
- Perform document control activities, including the review and approval of quality documents and records.
- Conduct training for the awareness of quality objectives, regulatory and QMS requirements.
Quality Assurance and Regulatory Affairs Manager
Maysa Medical Industry and Trade Ltd.
09.2021 - 09.2022
- For Class IIa MD, Managing ISO 13485 and MDD- CE audits (including internal audits), following the calibration of measurement tools, Following up on routine tests, Preparing instructions for all devices in the factory, Keeping training records, and keeping relevant records
- Preparing and updating the technical file by the 2017/745 EU MDR Medical Device Regulations, Managing CAPA for internal and external complaints
Intern Engineer
Nukleon Nuclear Technology Ltd. Co.
08.2020 - 09.2020
- Learned about; Microbiological tests and quality control of the radiopharmaceuticals QMS compliance with ISO 13485 incl
- SOP, documents, and records
- Trained in-house on Radiation Protection and GMP
Volunteer Intern
Ege UNIVERSITY Medical Biotech Laboratory
07.2019 - 09.2019
- Part of the Laboratory Experience Certificate, Doing microbiological laboratory studies for 40 working days
Education
Ege University - Bioengineering
Ege University
07.2021
Skills
- E-QMS
- ERP
- MATLAB
- Leadership
- Collaborative
- Results-oriented
- Self-confident
- Self-improvement
- Initiative
- Courage
- Commonsensical
Certification
- Responsible Manager Certificate of Competency, TITCK -Turkiye Medicine and Medical Device Institution, 06/01/22
- Clinical Support Staff Certificate of Competency, TITCK -Turkiye Medicine and Medical Device Institution, 06/01/22
- Sales and Promotion Staff Certificate of Competency, TITCK -Turkiye Medicine and Medical Device Institution, 06/01/22
- ISO 13485:2016 Medical Devices QMS Internal Auditor, Q&P Quality Production Systems, 01/01/22
- MDR 2017/745 Medical Device Regulation Training, Chamber Of Commerce, Izmir, 01/01/22
- MDR 2017/745 Mini-Course, Easy Medical Device, 01/01/22
- PCR Webinar Participate, Lab Akademi, 02/01/21
- ISO 13485 Medical Devices Management System Training, Taksim Consultancy Services, 10/01/20
References
- Tamer YAGAN, General Manager, Nukleon Nuclear Technology Industry and Trade Ltd. Co., tamer@nukleon.com.tr, +902124837334
- Prof. Dr. Elif Esin HAMEŞ TUNA, Department of Bioengineering, Ege University, esinhames@gmail.com, +902323115811
Languages
Turkish
Native language
English
Advanced
C1
Timeline
Quality Officer
Philips Medical Systems
06.2024 - Current
Quality Assurance Officer
Reboocon Bionics B.V.
09.2022 - 06.2024
Quality Assurance and Regulatory Affairs Manager
Maysa Medical Industry and Trade Ltd.
09.2021 - 09.2022
Intern Engineer
Nukleon Nuclear Technology Ltd. Co.
08.2020 - 09.2020
Volunteer Intern
Ege UNIVERSITY Medical Biotech Laboratory
07.2019 - 09.2019
Ege University - Bioengineering
Ege University
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