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Group Quality Management System Manager
Il y a 5 mois
We are EssilorLuxottica, 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 over 180,000 dedicated employees in 150 countries driving our iconic brands, our people are creative, entrepreneurial and celebrated for their unique perspectives and individuality. Committed to vision, we enable people to “see more and be more” thanks to our innovative designs and lens technologies, exceptional quality and cutting-edge processing methods. Every day we impact the lives of millions by changing the way people see the world.
Classification : F12
Reporting to the Head of Group Quality System, the Group Quality Management System Manager works on the following missions:
Shape and Design the Group Ophthalmic lens Quality System as per all applicable Medical devices regulations, standards and best practices Maintain the compliance of the group QMS and continuously adjust it to the different External regulatory evolutions and the internal business needs and transformation. Support the quality certification process of Legal Manufacturers and Manufacturing sites from a global QMS perspective Develop and manage a worldwide network to maintain and improve the Group QMS Be part of the Group Internal Auditor pool, and strongly contribute to the qualification of the Internal Auditors Support external inspections: Certified Bodies, Notified Bodies, Health Authorities inspections… Deploy and Maintain quality documentation system in the group.Scope:
Companies: All Entities linked to EssilorLuxottica Group for Ophthalmic Lenses business Regulations and Standards: Medical devices, active wearable devices, ISO 13 485, MDR, 21 CFR Part 820(FDA) This context will evolve with EssilorLuxottica Group structureCandidate Profile:
Holds a diploma in Engineering / Biology / Pharmacy / Quality Experience of Quality system management or design new system in medical device fields Previous exposure on a multinational / global scope is a must as well as good knowledge of the the following regulations : ISO 13 485, MDR, 21 CFR Part 820(FDA) Excellent technical writing skills in English is a must (Able to map processes and create comprehensive yet accurate process and procedures), French and/or Italian is a plus Initiative and autonomy in a cross-functional position in an international Group. Self-development capacity. Communication and influence skills at multiple level: from top management to operators Extended experience with Quality Transversal network management & Team Building Capacity to transfer knowledge Good interpersonal skills and business focus. Knowledge of ophthalmic industry is a plus