Quality Assurance Specialist

This role is responsible in the implementation and maintenance of Quality Management System of SADC in Singapore in accordance to ISO 13485 and TradeFIRST requirements.

•Assist to develop and maintain Quality Management System(QMS) in compliance with ISO 13485
•Responsible for document control, change control and training management
•Assist QA Management in preparation of materials and follow up actions for Management Review and management meetings.
•Monitor and ensure activities required for maintenance of QMS are performed, including risk management, supplier management and internal audit
•Administer or coordinate Livelink, PLM, Learning Management System (LMS) and Trackwise in Singapore.
•Develop documentation system, maintain controls and documentation procedures
•Perform qualification, verification or User Acceptance Tests of software or changes to software
•Perform QC work in the absence of QC Specialist
•Analyze data to identify areas for improvement in quality system.
•lnvestigate 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 CAPA.
•Participate in and monitor Risk Management activities related to SADC processes and softwares.
•Verify and document any defects found during inspection of products and liaison with Cook Manufacturers.
•Perform any product recalls from international countries with Cook distribution.
•Perform supplier qualification, audit, corrective action request and improvement
•Perform duties related to QMS based on Singapore Customs requirements
•Have a sound understanding of, and comply with, the Cook Code of Conduct and Company compliance requirements
•Perform any other duties assigned by QA Management

• At least 3 years working experience as quality assurance in the medical device field.
• Degree in Science, Engineering or other related discipline.
• Experience in adverse event assessment and reporting for Singapore.
• Experience in Field Safety Corrective Action execution and reporting for Singapore.
• Experience in multinational medical device company preferred.

• Excellent communication and interpersonal skills, able to work with people from different levels internally and externally.
• Excellent time management and organizational skills. Able to perform duties with limited supervision and meet deadline.
• Fluent in English (both spoken and written).
• Skilled in document management.
• High level of computer skills including Microsoft Office.
• Multi-tasks and able to prioritize the job tasks, depending on the urgency.
• Positive attitude, be good team player and attend to details.