Lead the support for further development of the Company. QMS compliant to ISO 13485: 2016, FDA 21 CFR 820, and all other applicable medical device regulations, and also aligned with the Company QMS
Update and write SOPs and procedures in further development of the Company QMS
Assure compliance of processes with 21 CFR 820 Quality System Regulation and ISO 13485:2016
Ensure critical business and QMS processes are established, implemented and maintained
Support the further Implementation and management of Quality System version and document control
Support document retention and archiving systems
Conduct and coordinate annual internal audits as per predetermined schedule or as required
Establish and maintain procedures for process qualification and validation
Establish and maintain procedures to control nonconforming products and to prevent mix-ups
With department managers, plan and monitor business critical documentation review schedules
With department managers, identify and implement internal controls required for business-critical processes
Identify gaps or non-conformance in business-critical process and work with management to resolve in line with best business practices
Review and identify continual improvements as required within the quality manual and policies and procedures necessary to the quality system
Prepare and present report to summarize the result of internal audits, CAPA/NCR and any opportunities for improvement to management team for review
Report to Vice President of QA/RA on performance of the Quality Management System
Work with Customer Service and Logistics at Company with respect to import requirements of the FDA in order to enhance procedures for facilitating importation of products
