QA Executive

2 weeks ago


Singapore BIOPTIMAL INTERNATIONAL PTE. LTD. Full time
Ensure customer complaints are documented, investigated and closed on a timely manner according to timelines stated in the procedure.

  • Ensure product models' UDI-DI are registered in the GS1 system periodically.
  • To act as a Document Controller and ensure that QMS documents are maintained, updated and archived to the latest versions of the documents.
  • To act as the eQMS administrator and ensure that documents routed for approval are reviewed and approved within the agreed timelines.
  • Ensure that measuring devices are calibrated according to calibration frequency without disrupting the operations.
  • Ensure that products are quality checked and complied to specifications or customer requirements prior to release for distribution and shipment.
  • To act as a backup for QA Inspector in performing product lot release inspection in case of leave or absence from work.
  • Ensure that products are sterilized, and sterilization reports are complete and compiled.
  • Perform and document the yearly Ethylene Oxide (EtO) sterilization qualification.
  • Ensure that CAPAs are raised, investigated and closed in a timely manner according to procedure.
  • Ensure that NCIRs are raised, investigated and closed in a timely manner according to procedure.
  • Ensure data analysis and trend reporting of NCIR, CAPA and customer complaints.
  • Update applicable SOPs, WIs, Forms and Templates as and when required to comply with regulations.
  • Support the Return Goods Process initiated by CS department.
  • Support the Internal Audit and External Supplier Audit according to ISO 13485 / ISO 9001 or internal procedure requirements.
  • Ensure that Inspection, Measurement and Testing Equipment (IMTE) are validated prior to operational use.
  • Perform the customer complaint investigation of returned sample/s including the drafting the Investigation Report for issuance to customer.
  • Perform other relevant tasks for QA Department (E.g. PO creation in SAP, document delivery, administrative duties, etc.).
  • Any other adhoc duties as assigned by Manager.

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