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.,

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

- 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

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