1.Develop, implement, and maintain the organization's quality management system in alignment with applicable standards and regulations, such as ISO 9001, FDA regulations, and industry-specific requirements.
2.Serve as the primary point of contact and subject matter expert for all matters related to quality management, including audits, inspections, certifications, and customer inquiries.
3.Lead internal audits to evaluate the effectiveness of the QMS, identify areas for improvement, and ensure adherence to quality objectives and procedures.
4.Coordinate external audits and inspections conducted by regulatory agencies, certification bodies, and customers, ensuring timely responses and corrective actions as needed.
5.Facilitate the development and implementation of quality objectives, policies, procedures, and performance metrics throughout the organization.
6.Provide guidance, training, and support to quality management representatives and other stakeholders on quality management principles, practices, and documentation requirements.
7.Monitor and analyze quality performance data to identify trends, root causes of non-conformities, and opportunities for preventive action and continuous improvement.
8.Lead or participate in cross-functional teams to address quality-related issues, implement corrective actions, and drive initiatives to enhance quality and operational efficiency.
9.Maintain accurate and up-to-date documentation related to the QMS, including procedures, records, certifications, and compliance documentation.
10.Collaborate with suppliers and subcontractors to ensure adherence to quality requirements, standards, and specifications, including conducting supplier audits and evaluations as necessary.