Quality Assurance Specialist

Requisition ID
# of Openings
Job Location(s)
Singapore Singapore
Bachelor's Degree
Position Type
Full Time
Expiry Date


Support QA Manager in the implementation and maintenance of Quality Management System in Singapore in accordance to ISO 13485.


  • Assist to develop and maintain Quality Management System in compliance with ISO 13485.
  • Responsible for document control, change control, training management.
  • Assist QA Manager and Management in preparation of materials and follow up actions for Management Review.
  • Responsible to monitor and ensure activities required for maintenance of QMS are performed, including for risk management, supplier management and internal audits.
  • Assist in Livelink and Learning Management System (LMS) in Singapore.
  • Develop documentation system, and maintain controls and documentation procedures.
  • Perform training of Quality documents.
  • Perform qualification, verification or User Acceptance Tests of software or changes to software.
  • Analyse data to identify areas for improvement in quality system.
  • Investigate Customer complaint and non-conformance issues and monitor to ensure closure.
  • Coordinate the Corrective and Preventive Action (CAPA) system and monitor to ensure timely closure.
  • Perform internal audits and follow up with departments on CAPAs.
  • Participate in and monitor Risk Management activities related to SADC processes and software.
  • Verify and document any defects found during inspection of products and liaison with Cook Manufacturers.
  • Perform any product recalls from APAC countries with Cook distribution.
  • Perform supplier qualification, audit, corrective action request and improvement.
  • Perform as back-up for QC inspection and other duties.
  • Perform duties related to QMS based on Singapore Customs requirements.


  • 2- 5 years’ experience in Quality Assurance in a medical device or equivalent field.
  • Resourceful and possess initiative, and a thinking mindset.
  • Ability to multi-task.


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