QARA Assistant (Contract) - #1108491

JOB RESPONSIBILITIES

• Ensure that documents routed for approval are reviewed and approved in KeyApp within the agreed timelines and maintained in the Server Files.

• Ensure the QMS documentation are drafted, maintained, updated and archived to the latest versions of the documents.

• Ensure the products’ UDIs are up-to-date and maintained in different regulatory platforms.

• Ensure customer complaints are documented, investigated and closed on a timely manner according to timelines stated in the procedure.

• Ensure the current standards and common specifications are available for use anytime.

• Ensure the measuring devices are calibrated according to calibration frequency without disrupting the operations.

• Ensure expired and/or contaminated devices and expired documents are disposed properly according to the procedure.

• To act as a backup of the QA Inspector in performing product lot release inspection in case of leave or absence from work. Alternatively, to act as backup of the QA Executive in performing the labelling changes, release of products, sterilization conformance and other urgent QA related handed over tasks.

• Extend support to other relevant tasks for QARA Department (i.e., PO creation in SAP, document delivery, administrative duties, etc.)

• Any other ad-hoc duties as assigned by Manager and Executives.

JOB REQUIREMENTS

• Graduate of any science-related course (degree preferred) with at least 1 year of Quality Assurance 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.

- 1-year renewable contract
- Potential for conversion to a permanent position
- Office located within a 5-minute walk from Kaki Bukit MRT station
- 5-day work week, Monday to Friday

(We regret that only shortlisted candidates will be contacted.)