QMS Coordinator

Requisition ID: 887249 
Position: Full-Time 
Total Rewards: Benefits/Incentive Information

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

• Education - Associates degree in a related field. Bachelors preferred. Six Sigma yellow, green or black belt preferred.
• 5-7 years of previous related experience in a like industry working in a lean environment
• Must possess the ability to plan, organize, develop, implement and interpret goals, objectives, policies and procedures of the organization.
• Competent – Business math skills and TQM practices and principles required
• Ability to effectively present information and respond to questions from groups of managers and employees.
• Ability to multi-task and prioritize.
• Demonstrate good judgment, critical thinking, problem solving skills and decision-making skills.
• Proficient to Expert in the use of Microsoft Office programs including Microsoft Word, Microsoft Excel, and Outlook.
• Ability to learn how to use additional systems, computer operated machinery, and cloud based software.

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. 
 
Upon request and consistent with applicable laws, EssilorLuxottica will provide reasonable accommodations to individuals with disabilities who need assistance in the application and hiring process.  To request a reasonable accommodation, please call the EssilorLuxottica SpeakUp Hotline at 844-303-0229 (be sure to provide your name and contact information so that we may follow up in a timely manner) or email HRCompliance@luxotticaretail.com. 
  
We are an Equal Opportunity Employer.  All qualified applicants will receive consideration for employment without regard to race, color, gender, national origin, social origin, social condition, being perceived as a victim of domestic violence, sexual aggression or stalking, religion, age, disability, sexual orientation, gender identity or expression, citizenship, ancestry, veteran or military status, marital status, pregnancy (including unlawful discrimination on the basis of a legally protected pregnancy or maternity leave), genetic information or any other characteristics protected by law. Native Americans in the US receive preference in accordance with Tribal Law.