Job Description

Requirement

• To ensure implementation and compliance with the requirement of documented quality management system that meets ISO13485 standard and other regulatory standard as applicable
• Coordinate in preparation of different types of regulatory submission to competent authorities for product registration
• Organize and manage QA/Lab department and ensure required training is carried out and availability of resources
• Involve in document and record control, risk management, post market surveillance, nonconformance/CAPA
• Involve in document and record control, risk management, post market surveillance, nonconformance/CAPA management, change control, supplier quality, manufacturing quality, calibration, and data analysis
• Authorise COA, COC and/or COI and other relevant record for product release
• Support marketing on label changes and marketing material review as needed
• Keep abreast of industry regulatory news and update on guidelines, standards etc and ensure that all in-house systems and procedures are updated, revised and modified to meet the requirements
• Arrange sample for routine sterilization dose audit and obtain approval on dose audit report
• Prepare, review and revise procedure, technical report and other document as per QA documentation requirement
• Any other jobs as directed by superior or Management
• Education : At least Diploma / Degree in any related field
• Experience : Preferably 1-2 Year of working experience in related field
• Skills : Analytical skill, Microsoft Excel, English, Malay

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