Group Quality Management System Director

il y a 4 semaines


Créteil, Île-de-France EssilorLuxottica Temps plein

We are EssilorLuxottica, a global leader in the design, manufacture, and distribution of ophthalmic lenses, frames, and sunglasses. Our company brings together the complementary expertise of two industry pioneers to create a vertically integrated business that addresses 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.

Classification: F12

The Group Quality Management System Manager plays a crucial role in shaping and designing the Group Ophthalmic Lens Quality System, ensuring compliance with all applicable medical device regulations, standards, and best practices.

Key responsibilities include:

  • Developing and maintaining the Group QMS, 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.
  • Developing and managing a worldwide network to maintain and 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.
  • Deploying and maintaining quality documentation systems within the group.

Scope:

  • Companies: All entities linked to the 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 the EssilorLuxottica Group structure.

Candidate Profile:

  • Holds a diploma in Engineering, Biology, Pharmacy, or Quality.
  • Experience in Quality system management or design of new systems in medical device fields.
  • Previous exposure to a multinational/global scope and good knowledge of regulations ISO 13 485, MDR, 21 CFR Part 820 (FDA).
  • Excellent technical writing skills in English, with French and/or Italian being a plus.
  • Initiative and autonomy in a cross-functional position in an international Group.
  • Self-development capacity.
  • Communication and influence skills at multiple levels.
  • Extended experience with Quality.
  • Transversal network management and Team Building.
  • Capacity to transfer knowledge.
  • Good interpersonal skills and business focus.
  • Knowledge of the ophthalmic industry is a plus.


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