Every role at CTK makes an impact on improving global health! As you bring your talent to the global market, you will make a positive impact on global healthcare by supporting an array of diagnostic products.
This position reports directly to QA Manager and the Management Representative. The ISO 13485 QA Specialist will be responsible for ensuring compliance with quality standards and regulations, primarily focusing on the ISO 13485 standard. The QA Specialist will support the development, implementation, and maintenance of quality management systems, procedures, and policies, and will provide guidance to employees on compliance issues. The ISO 13485 QA Specialist will also oversee internal audits, coordinate external audits, and manage non-conformances and corrective and preventive actions.