Anna Kocsis
Quality Assurance Officer @OrganOx
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WORK HISTORY
Quality Assurance Officer @OrganOx
Oxford, GB
Review and approval of Device History Records and QA release of new products. QA review and approval of service records, reworks and test reports. Working closely with service engineers on resolving issues and approving documentation. Supplier liaison regarding quality issues and outstanding actions. Handling Non-Conformances, CAPAs, Complaints, and Supplier Corrective Action Reports by raising, investigating and closing open records in the eQMS and engaging with subject matter experts from different levels of the company. Providing training on the use of the eQMS, device release process, and relevant procedures. Creating, updating, reviewing and releasing relevant SOPs, Work Instructions and Forms in the eQMS. Part of a cross-functional FMEA group for risk assessment Maintaining supplier approval records, and conductiong periodic re-evaluation of suppliers Conducting and supporting internal- and external audits Holding ISO13485 Lead Auditor certification
EDUCATION
Pázmány Péter Katolikus Egyetem
Master of Science (MSc), Medical Biotechnology
Pázmány Péter Katolikus Egyetem
Bachelor of Science (BSc), Molecular Bionics Engineering
Kodolányi János University College
Bachelor of Arts (BA), English Language and Literature, General
SKILLS
ABOUT ANNA KOCSIS
Quality Assurance Officer at OrganOx
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