Group Quality Management System Manager
il y a 2 semaines
We are EssilorLuxottica, a global leader in advanced lens technologies and the craftsmanship of iconic eyewear. Our Company brings together two industry pioneers to create a vertically integrated business that addresses the evolving vision needs and the global demand of a growing eyewear industry.
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.
As a key member of our team, the Global Quality Management System Manager will be responsible for:
- Developing and maintaining the Group Ophthalmic lens Quality System according to Medical devices regulations, standards, and best practices
- Ensuring the compliance of the group QMS and continuously adapting it to external regulatory evolutions and internal business needs
- Supporting the quality certification process of Legal Manufacturers and Manufacturing sites from a global QMS perspective
- Establishing and maintaining a worldwide network to improve the Group QMS
- Participating in the Group Internal Auditor pool and contributing to the qualification of Internal Auditors
- Supporting external inspections, including Certified Bodies, Notified Bodies, and Health Authorities
- Maintaining quality documentation systems across the group
Scope:
- Companies: All Entities related to EssilorLuxottica Group for Ophthalmic Lenses business
- Regulations and Standards: Medical devices, active wearable devices, ISO 13485, MDR, 21 CFR Part 820(FDA)
- This context will evolve with EssilorLuxottica Group structure
Candidate Profile:
- Hold a diploma in Engineering, Biology, Pharmacy, or Quality
- Experience in Quality system management or design for medical device fields
- Previous exposure to multinational/global scope is a must, along with knowledge of ISO 13485, MDR, 21 CFR Part 820(FDA) regulations
- Excellent technical writing skills in English are required, with French and/or Italian being a plus
- Initiative and autonomy in a cross-functional position are essential
- Self-development capacity and communication skills at multiple levels are required
- Extended experience with Quality and transversal network management are beneficial
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