Sezgin Gyuney
Quality Assurance Specialist - Capa Coordinator @Beckman Coulter Diagnostics
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WORK HISTORY
Quality Assurance Specialist - Capa Coordinator @Beckman Coulter Diagnostics
As a dedicated CAPA Coordinator, I meticulously manage Corrective and Preventive Action (CAPA) processes, including problem statements, root cause analysis, corrective and preventative actions, tracking timelines, and establishing CAPA files. I ensure effective and efficient execution of CAPA activities.My role centers on promptly resolving quality deviations by identifying issues and conducting comprehensive root cause analyses. Through collaboration with cross-functional teams, I foster effective communication and synergy to drive sustained product excellence.I also monitor and evaluate the effectiveness of the CAPA system, implementing necessary changes to enhance its efficiency and aligning it with regulatory requirements. Additionally, I provide support and training on SMARTSOLVE, EDMS, and MasterControl to maximize their benefits in CAPA processes.Leveraging my regulatory expertise, I navigate the complex quality assurance landscape, ensuring CAPA processes meet expectations and mitigate risks. Continuous improvement is fundamental, as I strive to enhance product reliability and customer satisfaction by identifying areas for refinement.In summary, as a CAPA specialist and Coordinator, I proactively identify opportunities for improvement, driving meaningful change while upholding high standards. I shape our organization towards sustained growth and excellence.
EDUCATION
Balıkesir University
Bachelor of Engineering (B.E.)
SKILLS
ABOUT SEZGIN GYUNEY
Dedicated Quality Engineer and Product Lifecycle Management Specialist with over 9 years…
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