Ensure that all quality control processes and procedures align with relevant regulatory requirements, such as ISO 13485, FDA (U.S. Food and Drug Administration) regulations, and other international standards specific to medical devices
Establish and maintain a robust QMS that covers all aspects of quality control, including documentation, training, and audits.
Establish and maintain a robust QMS that covers all aspects of quality control, including documentation, training, and audits.
Oversee the inspection and testing of medical devices to ensure they meet specified quality standards. This includes setting up testing protocols
Develop procedures for handling nonconforming products and implementing corrective and preventive actions (CAPA) to address and prevent recurring issues.
Collaborate with the supply chain and procurement teams to evaluate and ensure the quality of materials and components supplied by external vendors.
Maintain accurate and up-to-date records related to quality control, including specifications, test results, and compliance documentation
Provide training to quality control personnel to ensure they have the necessary skills and knowledge to perform their roles effectively.
Investigate the root causes of quality issues and implement corrective actions to prevent their recurrence.
Develop and execute risk management strategies to identify and mitigate potential risks in the production and use of medical devices.
Prepare for and participate in regulatory audits and inspections, ensuring that the organization is compliant with all applicable standards and regulations
Drive continuous improvement initiatives within the quality control department, using data and feedback to enhance processes and reduce defects.
Provide regular reports to senior management on the performance of the quality control department, including metrics, key findings, and areas of improvement
Manage the process of changes to products or processes, ensuring that these changes are well-documented, reviewed, and approved while maintaining quality standards.
Ensure that products are only released to the market after they have passed all quality control checks and meet the necessary regulatory requirements
Supervise and lead a team of quality control professionals, providing guidance, training, and support to achieve department goals.
