QARA Assistant (Contract)

BIOPTIMAL INTERNATIONAL PTE. LTD.; Singapore; On-site; SGD 20,000 - 60,000; Full time

Job summary

A leading medical device company in Singapore seeks a Quality Assurance professional to manage documentation, customer complaints, and support inspection tasks. The ideal candidate has a science degree, 1+ years of QA experience, and is adaptable in a fast-paced setting. Benefits include a 1-year renewable contract and opportunities for permanent employment.

Benefits

1-year renewable contract

Potential for conversion to permanent position

5-day work week

Qualifications

• 1+ year of Quality Assurance experience in a fast-paced environment.
• Fluent in both verbal and written English.
• Exposure to document control systems is an advantage.

Responsibilities

• Ensure timely review and approval of documents.
• Document and investigate customer complaints.
• Act as backup for QA inspections and administrative tasks.

Skills

Quality Assurance

ISO 9001 Knowledge

Document Control

Customer Complaint Handling

Interpersonal Skills

Education

Graduate of any science-related course

Job description

JOB RESPONSIBILITIES

1. Ensure that documents routed for approval are reviewed and approved in KeyApp within the agreed timelines and maintained in the Server Files.
2. Ensure the QMS documentation are drafted, maintained, updated and archived to the latest versions of the documents.
3. Ensure the products’ UDIs are up-to-date and maintained in different regulatory platforms.
4. Ensure customer complaints are documented, investigated and closed on a timely manner according to timelines stated in the procedure.
5. Ensure the current standards and common specifications are available for use anytime.
6. Ensure the measuring devices are calibrated according to calibration frequency without disrupting the operations.
7. Ensure expired and/or contaminated devices and expired documents are disposed properly according to the procedure.
8. 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.
9. Extend support to other relevant tasks for QARA Department (i.e., PO creation in SAP, document delivery, administrative duties, etc.)
10. 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.

Benefits

• 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.)