Quality Assurance Executive

JOB DESCRIPTION

• 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 e-QMS (Keyapp) 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.

• 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.).

• Provide Regulatory requirement guide to internal teams for countries submission.

• Provide regulatory support to R&D team in strategic planning, pre-marketing, and related submissions to support optimal timelines for new and changed product launches.

• Any ad-hoc duties as assigned by reporting line manager.

REQUIREMENTS

• Degree in Biomedical Science or any related science field.

• At least 3 years of experience in Quality Assurance within a manufacturing environment.

• Minimum 1 year of experience in quality inspection and compliance with quality/control plans.

• Certified in ISO 13485 training and Certified in ISO 14971 training.

• Knowledge of Quality and Root Cause Analysis (RCA) tools.

• Familiar with applicable international standards and product specifications.

• Self-motivated and able to work independently.