QARA Assistant (Contract 2 Years)

JOB RESPONSIBILITIES

• Ensures customer complaints are handled properly, and investigation reports are completed without delay.

• Ensures reportable customer complaint cases are reported to USFDA ESG NextGen Unified Submission Portal (USP).

• Ensures product UDI are registered on time to different regulatory databases and platforms (EUDAMED, USFDA GUDID, GS1, etc.)

• Ensures Certificate of Origin (COO) is endorsed by the Chamber of Commerce during product shipment.

• Ensures product inspection and lot release are completed on time when the QA Inspector is not available.

• Ensures Temp. and RH monitoring of the warehouses are carried out in accordance with the frequency.

• Ensures pest control activities are carried out properly by the external vendor according to the pest control plan and procedure.

• Ensures monitoring and measuring devices are calibrated prior to its expiry date.

• Coordinates the translation of documents and ensures accuracy of translation.

• Ensures COC, COA and COS are created and provided to CS or customer on a timely manner.

• Ensures expired devices and documents are disposed properly by the external vendor.

• Ensures Document Management System (KeyApp) and QMS shared folders are up to date and in order.

• Provides support on ad hoc tasks as may be assigned by the superiors from time to time.

JOB REQUIREMENTS

• Graduate from any Science related course with at least 1 year Quality Assurance related experience, preferably in a fast-paced environment.

• Fluent in both verbal and written English is preferred.

• Knowledge in ISO 9001 or ISO 13485 Quality Management System (QMS) is preferred but not mandatory.

• Exposure to any document control system will be an advantage.

• Exposure to customer complaint handling and Quality Inspection will be an advantage.

• Experience in a medical device company or equivalent will be an advantage.

• With good interpersonal and communication skills, positive outlook and able to get along with peers.

• Self-starter and independent with less supervision needed is preferred.

• Flexible and highly adaptable to fast-paced environment.

• Open minded, active listener and willing to learn.