Roxana Litwa
About Roxana Litwa
Roxana Litwa is a Quality Specialist at Teleflex in Bad Liebenzell, Germany, with expertise in DIN EN ISO 13485 and DIN EN ISO 14971 standards.
Company
Roxana Litwa is currently employed at Teleflex, a global provider of medical technologies, based in Bad Liebenzell, Baden-Württemberg, Deutschland. Teleflex is known for delivering innovative solutions in areas such as vascular and interventional access, surgical, anesthesia, cardiac care, urology, and emergency medicine. Roxana contributes to the company's mission by ensuring quality standards in medical products and processes.
Title
Roxana Litwa holds the position of Quality Specialist at Teleflex. In this role, she is responsible for overseeing and maintaining the quality of products and processes in the company. Her duties involve rigorous standards compliance, quality control, and implementation of corrective and preventive actions to address any issues in the production process.
Background
Prior to her current role, Roxana Litwa worked as a Qualitätsmanagement Fachkraft at Teleflex from 2019 to 2021. Her experience during this period helped her build a strong foundation in quality management practices, setting the stage for her current role as a Quality Specialist.
Education and Expertise
Roxana Litwa completed her education at the Humanistische Gymnasium in Brasov, Rumänien, where she achieved her Abitur. She has developed expertise in the DIN EN ISO 13485 and DIN EN ISO 14971 standards, both critical for quality management in the medical device industry. Roxana specializes in quality control and microbiology, which are essential for ensuring the safety and effectiveness of medical products.
Quality Control and Microbiology
Roxana Litwa possesses specialized skills in quality control and microbiology. These areas are critical in her role at Teleflex, where she ensures that products meet stringent quality and safety standards. Her proficiency aids in thorough inspection and validation of procedures and outcomes in the manufacturing process.
CAPA and Non-Conformance Management
Roxana is experienced in managing Corrective and Preventive Actions (CAPA) and Non-Conformance (NC) events. These responsibilities include identifying root causes of issues, implementing solutions, and preventing recurrence. Her expertise ensures continuous improvement in product quality and compliance with regulatory standards.
Change Management and Training Systems
Roxana Litwa is also proficient in change management and the administration of training systems. These skills are crucial for adapting to new processes and ensuring that all personnel are adequately trained to maintain high-quality standards. Her role involves overseeing changes in procedures and effectively managing the transition to new quality protocols.