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Overview:
Responsibilities:
Qualifications:
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.
Responsibilities:
- 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
Qualifications:
- 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.
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