QMS Engineer

EssilorLuxottica, a fully integrated player, is a global leader in the design, manufacture and distribution of ophthalmic lenses, frames and sunglasses.

The company brings together the complementary expertise of two industry pioneers, one in advanced lens technologies and the other in the craftsmanship of iconic eyewear, to create a vertically integrated business that is uniquely positioned to address the world’s evolving vision needs and the global demand of a growing eyewear industry.

With a worldwide presence across all stages of the value chain, EssilorLuxottica has over 180,000 employees committed to providing vision care and eyewear products that meet the individual needs and aspirations of each consumer. Our unique business model and relentless pursuit of operational excellence ensures that consumers everywhere have access to products that have been rigorously tested to meet internationally recognized standards, from the simplest pair of glasses to the most sophisticated custom-made lenses and branded eyewear.

By investing heavily in R&D for cutting edge lens and frame technology, as well as reimagining the design, form and function of eyewear, EssilorLuxottica constantly sets new industry standards for vision care and eyewear and the consumer experience around it. Beyond the products we make, our company and our people are deeply committed to elevating the importance of vision as both a basic human right and a key lever for global development.

For more information, please visit www.essilorluxottica.com

Position:  QMS Engineer 

Location:  Amata, Chonburi

Job Family: Quality Management System

Expertise: Quality Management System, Software Validation, CAPA and Audit

This role will take the lead of Essilor Luxottica global quality system CAPAs (From Audits, Inspections, Others…) process globally to ensure the sustainability and the effectiveness of the global QMS.

Support the needs of QMS Global audit program.

Strong focus on Software Validation compliance ensuring sustained regulatory compliance, audit readiness and business continuity across global operations.

Support the improvement and adjustment of Global QMS and Global standards for an effective deployment and continuous compliance to new regulations and or business needs or organization transformation.

 Job Responsibilities:

• Lead the Global QMS CAPAs process and driving cross-function on global problems solving and process improvement related to quality system to ensure effective and sustainable quality practices.
• Acts as Subject Matter Expert (SME) for Software Validation, supporting the design, implementation and continuous improvement of global Software Validation process in alignment with ISO 13485, GMP and applicable regulatory expectations.
• Ensure Software Validation compliance is embedded into QMS processes, recognizing its critical role in audit readiness, regulatory inspections and operational continuity.
• Continue the maintenance and effectiveness of QMS implementation based on Essilor Luxottica Group Quality System and related quality standard requirement.
• Organize and perform quality audits to assess compliance and identify areas for improvement, ensuring readiness for audits by Certification Bodies and competent Authorities and ensure quality system comply with Essilor Luxottica group quality system and related quality standard requirement.
• Follow up, monitor CAPAs WW (CAPAs from global Audits, Certification Audits, Competent Authorities Inspections, etc.), and leverage effective solutions for global deployment.
• Promote and establish a continuous improvement culture by initiate and leading global quality project to enhance and harmonize QMS workflows in alignment with Medical Device Regulations, and promote the culture of “Find it once, fix it everywhere”.
• Collaborate with global stakeholders to embed quality into core operations and drive strategic alignment across each area and functions.

Requirements

• Bachelor / Master degree in Engineering  or Science in the field of Chemistry / Material /Industrial /Physical

/ Electrical / Mechanical or its equivalent.

• Desirable/Preferable: Knowledge of quality system minimum requirement but not limit to: ISO13485, ISO9001, GMP and ISO14971– however applicants from other industries are also encouraged to apply.
• Enrich with quality mindset in Medical Devices or Healthcare environment and have systematic and logical thinking.
• Solid knowledge of Quality system (Document control, Quality audit, Management of change, Risk management, Software Validation and computerized systems compliance within a regulated environment, CAPA)
• 3-5 year of working experience in Essilor Luxottica or Globally organization is advantage.
• Project management skills and know- how will be an advantage
• Proficient in MS Applications (Excel, Word, PowerPoint, SharePoint, Visio)
• Proficient in English (read, write, speak) and may require to travel in the zone around 10-20%
• Non-technical skill required; leadership, organization skills, clear and effective communication, logical thinking, action and result oriented ability to animate and mobilize the teams.

Our Diversity, Equity and Inclusion commitment​

We are committed to creating an inclusive environment for all employees. We celebrate diversity and provide equal opportunities to all, regardless of race, gender, ethnicity, religion, disability, sexual orientation, or any other characteristic that makes us unique.