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.

BIOPTIMAL INTERNATIONAL PTE LTD

, a publicly-traded, multi-national corporation headquartered in Singapore is seeking highly-motivated individuals to join our dynamic team to continually develop, manufacture and commercialize innovative medical devices used in interventional cardiology and critical care procedures.