Role
Duties & Responsibilities
- 01) To ensure all the product specification for all new/ development products are prepared and released within the deadline given
- 02) Prepare a proper guideline for the evaluation report procedure which compulsory to follow by QA factories to conduct evaluation for new/improved products before submit complete evaluation report for the management approval and proceed with product spe
- 03) To ensure all the evaluation reports submit by QA factory are reviewed and followed with product specification issuance if all the test results comply with standard requirements
- 04) To ensure all new / developed products by R&D factory are fully evaluated by QA and complied with the necessary testing requirement before proceed with product specification issuance
- 05) Updated all new products developed by R&D factory into Approved Product & Producer List (APPL). The implementation of APPL will enhance the smoothness of the product specification issuance
- 06) Conduct training to Operation team for evaluation report procedure of new/ improved products
- 07) Prepared all required documents for 510(K) report submission to FDA for the USA shipment
- 08) Prepared our in house new barcodes which following GUDID requirement
- 09) Advised marketer on the suitable products (product matching) for their customers as per requirement given by their customers
- 10) Collaborate with marketing, branding, IT and operation team for product information in catalogue, TG Website, and brochure
- 11) Monitor SAP & maintain product code, lot numbering system for glove & non glove product
- 12) Glove submission to external lab for glove testing
- 13) Marketing enquiry regarding external test report with product compliance
- 14) To ensure all external test report has been tested according to latest standard requirement