The incumbent should manage incoming inspection, quality assurance, and quality compliance.
Develop, administer, and maintain quality assurance procedures and activities required to ensure that the company's processes and products comply with the medical device quality standards and requirements.
Ensure that all manufacturing and packing operations carried out at the in-house manufacturing site comply with current good manufacturing practices desirable.
To ensure that the products, packaging components, and labeling meet the local & out countries’ries regulatory requirements.
Coordinate and organize supplier audits, certification audits, customer audits, or other inspections. Execute and follow up on internal audit recommendations.
Perform investigations on non-conformances and customer complaint close out and corrective actions.
Maintains and demonstrates an understanding of global standards, regulations, and regulatory bodies including but not limited to ISO13485.
Write and review of SOPs and other quality assurance-related technical data forms and quality documents.
Proper maintenance of control documents in Quality Assurance
Experience in Postmarket Surveillance, and CAPA/FSCA handling.