QMS Coordinator
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![]() United States, Iowa, Sioux City | |
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Requisition ID:887249 If you've worn a pair of glasses, we've already met. We are a global leader in the design, manufacture, and distribution of ophthalmic lenses, frames, and sunglasses. We offer our industry stakeholders in over 150 countries access to a global platform of high-quality vision care products such as the Essilor brand, with Varilux, Crizal, Eyezen, Stellest and Transitions, iconic brands that consumers love such as Ray-Ban, Oakley, Persol and Oliver Peoples, as well as a network that offers consumers high-quality vision care and best-in-class shopping experiences such as Sunglass Hut, LensCrafters, and Target Optical, and leading e-commerce platforms. Our unique business model and relentless pursuit of operational excellence ensures that consumers everywhere have access to products. Balancing speed, efficiency and proximity, the Company manages a global supply chain with cutting-edge technology, based on centralization for frames and on a capillary network for lens finishing and prescription laboratories. In our dynamic environment, fueled by technology and innovation, our people have the space to pioneer new solutions. Join our global community of over 200,000 dedicated employees around the world in driving the transformation of the eyewear and eyecare industry. Discover more by following us on LinkedIn! GENERAL FUNCTION - The Quality Management System Coordinator is responsible for coordination of the quality management documentation. This position supports the leadership team in the implementation, maintenance, and the continuous improvement of the Quality Management System (QMS) in accordance with ISO 13485 standards. This role's administrative duties ensure compliance with regulatory requirements and promotes a culture of quality within the organization. MAJOR DUTIES AND RESPONSIBILITIES QMS Implementation and Maintenance: Develop, implement, and maintain the QMS in alignment with ISO 13485 standards as guided and directed by leadership. Work with leadership to ensure all processes required by ISO 13485 are established, documented, and practiced within the organization. Compliance and Regulatory Requirements: As directed, monitor and ensure compliance with relevant regulatory and statutory requirements for medical devices. Assignments will include conducting structured audits and assessments to verify adherence to ISO 13485 standards. Quality Policy and Objectives: Work with a management team to document definitions and communication of the quality policy and objectives. Report the progress of quality objectives throughout the organization to leadership using data collection and tracking tools. Continuous Improvement: Help to foster a culture of continuous improvement by identifying opportunities for process enhancements. Support administrative actions required to implement corrective and preventive actions for addressing non-conformities and improve QMS effectiveness. Training and Awareness: Cascade information to ensure that all employees are aware of the importance of compliance with customer and regulatory requirements. Facilitate or Co-facilitate established information sessions and trainings to communicate QMS processes and ISO 13485 requirements. Management Review: Gather data and prepare/present reports on the effectiveness of the QMS. Coordinate information to help management review and assess QMS suitability, adequacy, and effectiveness. Documentation and Record Keeping: Maintain accurate and up-to-date documentation of QMS processes, procedures, and records. Ensure proper control and retention of quality records in accordance with ISO 13485. BASIC QUALIFICATIONS: The requirements listed below are representative of the knowledge, skill, and/or ability required or preferred
Employee pay is determined by multiple factors, including geography, experience, qualifications, skills and local minimum wage requirements. In addition, you may also be offered a competitive bonus and/or commission plan, which complements a first-class total rewards package. Benefits may include health care, retirement savings, paid time off/vacation, and various employee discounts. |