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 Manufacturers.
- Perform any product recalls from international countries with 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 Code of Conduct and Company compliance requirements
- Perform any other duties assigned by QA Management
Requirement:
- At least 3 years working experience as quality assurance in the medical device field.
- Degree in Science, Engineering or other related discipline.
- Experience in multinational medical device company preferred.
If you are interested in exploring this role or other current openings in the market, kindly email me at [Confidential Information] with your resume.
We regret to inform that only shortlisted candidates will be notified.
Ashley Loo Yan Ni | R2095115 | EA License Number: 99C4599
Recruit Express Pte Ltd Company Reg. No. 199601303W
