Mai Tran Email & Phone Number

Vietnam

Ho Chi Minh City, Vietnam

Technical task:- Executed MDD-MDR gap assessment and gap remediation.- Be executor of p-CAPA of labeling standard assessment: analyze changes and their impact to product safety and performance, labeling, QMS, risk management, etc.,- Review standard gap assessment, product compliance checklist executed by cross-functional team.RA task: created and/or reviewed product registration dossiers such as: - GSPR checklist, Technical documentations, Standard compliance checklist and test report.- Applicable standard list, risk classification, DoC.QMS task: auditor for periodic internal audit, project QA.Others: - Value creation activities; Workgroup off China registration;- MDD-MDR gap assessment template, GSPR compliance sample;- Knowledge transfer regarding to MD classification, determine product applicable standard list, ISO/IEC standard naming rule, etc.,

Vietnam

R&D task:- Created documents, records related to R&D activities, such as: labeling design input, develop packaging/labeling artwork, labeling design verification/ validation, DHF, etc.,- Executed storage and transportation testing;Collaborate with other departments to proceed design change project;- Review labeling content based on GEO regulations, product standards, internal requirements.;- Co-ordinate with RA department to prepare product registration: GSPR/ER checklist, labeling set, technical documentation, test report.Management: - Took responsibility as a project leader for labelling related projects (released products, products under development, design changes or improvements)- To be single point of contact (SPOC) between project team and project manager and review stake holders.- Worked with suppliers to solve NCs or improve the material quality with appropriate cost

Ho Chi Minh City, Vietnam

- Documented, implemented and recorded R&D procedure to ensure they compliances with BS EN ISO 13485:2016.- Member of Risk management team: evaluated and controlled risks through out the product life cycle according to BS EN ISO 14971:2019- Collected and analyzed the market trends to upgrade the product so that they meet customer demand and increase the competition.- Update and look for suppliers for novel material or equipment to reduce the product price without affecting the product quality.- Collaborated with QA, QC, MFG and Procurement Departments to solve problems during production stage.- Worked with QA and RA to prepare and publish Product Enterprise Standards, Instruction for use (IFU), Catalogue, etc. - Be familiar with various international standards applied to medical devices

Ho Chi Minh City, Viet Nam

I did research on inkjet printer: nano-silver ink, luminescent ink for security application

Binh Duong Province, Viet Nam

No. 30, Lane 321, Yangxin N Rd, Yangmei District, Taoyuan City, Taiwan

Master'S Degree, Chemical Engineering

Thesis topic "Biosynthesis of Zinc oxide nanoparticles using aqueous Piper betle leaf extract and its application in surgical sutures".

Biomedical Material And Technology, 84.89/100

Activities and Societies: Part-time job: assistant Reseacher at YangMei Yeezenhospital, Taiwan Publication: "Bactericidal Effect of Lauric.

Engineer'S Degree, Chemical Engineering

Master'S Degree, Chemical Engineering