Eksekutif Jaminan & Kualiti

Sungai Petani, Malaysia

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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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