Quality Engineer

Role and Responsibilities Quality System Develop, implement and maintain QMS documentation to maintain compliance with applicable standards such as ISO 9001, ISO 13485 or GMP Monitor regulatory changes and update the QMS accordingly Conduct internal audits and support external audits (external auditing bodies, suppliers and customers) Analyze quality data and metrics to identify trends and areas for improvement Collaborate with cross functional teams to ensure that the quality standards are integrated into daily operations Ensure compliance with relevant regulations and industry standards such as FDA, CE, or ISO Develop and maintain procedures for corrective actions, nonconformities, and continuous improvement Identify and mitigate risks associated with product development, manufacturing, and supply chain management Provide training and support to employees on quality-related topics and ensure that they understand their roles and responsibilities in maintaining the quality system