QARA Assistant (Contract 2 Years)

BIOPTIMAL INTERNATIONAL PTE. LTD.; Singapore; On-site; SGD 47,000 - 71,000; Full time

Job summary

BIOPTIMAL INTERNATIONAL PTE. LTD. seeks a QA professional to manage customer complaints, QA investigations, and regulatory submissions. The role supports UDI registration, COO processing, and document control across the quality system.

The ideal candidate has 1 year QA experience in a fast-paced setting, strong English communication, and familiarity with ISO 9001/13485. Prior medical device exposure is a plus; independent work style is valued.

Qualifications

• Bachelor/Graduate with 1 year QA exposure in a fast-paced setting.
• Fluent in spoken and written English.
• ISO 9001 or ISO 13485 knowledge is preferred.
• Document control systems experience is a plus.
• Experience in medical device QA is advantageous.
• Strong interpersonal and communication skills.

Responsibilities

• Handle customer complaints; ensure investigations are completed without delay.
• Escalate and report compliant cases to relevant regulatory portals as required.
• Register product UDI across databases (e.g., EUDAMED, GUDID, GS1).
• Coordinate creation and endorsement of COO with Chamber of Commerce.
• Ensure product inspection and lot release when QA Inspector unavailable.
• Monitor warehouse temperature/humidity per schedule and assist pest-control activities.
• Verify calibration of measuring devices before expiry.
• Coordinate document translation for accuracy.

Skills

Quality Assurance

English Fluency

Document Control

Communication Skills

Self-starter

Education

Science Graduate

Tools

QMS System

Job description

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.