Technical Files Jobs in Malaysia

About The Role Responsible for ensuring that all medical device products and related operations comply with applicable regulatory requirements quality standards and company policies. This role will oversee the development implementation and continuous improvement of the Quality Management System (QM...

Job Responsibilities:1. Quality Management System (QMS) Establish implement maintain and continuously improve the Quality Management System (QMS) in compliance with:o ISO 13485o ISO 14971o FDA 21 CFR Part 820 / QMSRo MDSAP requirementso EU MDR requirements (where applicable)o Cust...

Position Description:Position DescriptionCompany Profile:Founded in 1976 CGI is among the largest independent IT and business consulting services firms in the world. With 94000 consultants and professionals across the globe CGI delivers an end-to-end portfolio of capabilities from strategic IT and b...

DescriptionResponsibilitiesFDA ResponsibilitiesPrepare and submit FDA/CDRH reports for new laser products product modifications and manufacturing location changes.Manage and maintain all accession numbers and ensure accurate linkage to product records.Compile validate and submit the annual FDA repor...