Perform the document control function for the company ensuring activities related to document control are compliant with the quality management system procedures and relevant regulatory requirements;
Draft and maintain quality system procedures and work instructions as required;
Performs batch disposition and release for supply activities by ensuring batch is produced according to product specifications and marketing authorization;
Assist with the handling of non-conformances, actively participate in investigations to determine root cause and the implementation of corrective/preventative actions;
Assist with change controls and project activities;
Assist in defining key product/service requirements for potential new suppliers as part of the supplier approval process;
Assist with internal and external audits;
Support the Change Control process to ensure changes are appropriately risk assessed and that any device design and/or process changes will not impact device safety, performance or efficacy;
Assist department managers with staff training needs related to the quality management system and maintain the company training matrix;
Support validation, product temperature excursions and customer complaints activities;
Comply with all company quality standards, procedures, and workplace health and safety requirements;
Operate within the requirements of the quality system and ensure responsibilities are carried out in accordance with the requirements of the applicable regulatory and quality processes;
Manage the development & maintenance of ISO 13485 procedures for regulatory and quality functions that ensure consistency with and compliance to the organization’s Quality Management system.
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