Job Summary:
The Quality Engineer is responsible for ensuring the quality and regulatory compliance of medical devices throughout the manufacturing process. This role involves developing and implementing quality assurance strategies, overseeing production processes, managing product quality, and ensuring adherence to industry standards and regulations. This will include support for new product transfers. Essential Duties and Responsibilities:
Include the following. Other duties may be assigned. . Quality Assurance and Control: - Develop, implement, and maintain quality assurance plans, procedures, and control measures. - Monitor and analyse production processes to detect and resolve quality issues. - Ensure compliance with relevant regulatory requirements, including FDA, ISO 13485, and other applicable standards. - Support internal and external audits and regulatory inspections. - Investigate and resolve product-related issues, deviations, and non-conformities, with the authority...