Quality Management System Manager
il y a 3 jours
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, 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.
The ideal candidate will have a diploma in Engineering, Biology, Pharmacy, or Quality and experience in quality system management or design in medical device fields. Previous exposure to a multinational or global scope is a must, as well as good knowledge of regulations such as ISO 13 485, MDR, and 21 CFR Part 820(FDA).
The Group Quality Management System Manager will work closely with the Head of Group Quality System to maintain the compliance of the group QMS and continuously adjust it to external regulatory evolutions and internal business needs.
The successful candidate will have excellent technical writing skills in English, with French and/or Italian being a plus. Initiative, autonomy, and self-development capacity are essential in this cross-functional position.
The Group Quality Management System Manager will be responsible for deploying and maintaining quality documentation systems, supporting external inspections, and contributing to the qualification of internal auditors.
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)
Candidate 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 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
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