QMS Engineer

If you’ve worn a pair of glasses, we’ve already met.

We are a global leader in the design, manufacture, and distribution of ophthalmic lenses, frames, and sunglasses. We offer our industry stakeholders in over 150 countries access to a global platform of high-quality vision care products such as the Essilor brand, with Varilux, Crizal, Eyezen, Stellest and Transitions, iconic brands that consumers love such as Ray-Ban, Oakley, Persol, as well as a network that offers consumers high-quality vision care and best-in-class shopping experiences and leading e-commerce platforms.

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Essilor Luxottica is one of the main actors in the Medical Device industry. The compliance to all the regulations in force is a key duty. Especially for the Innovation, as part of the Design & Development activities. To ensure this compliance, Innovation, under the leadership of Innovation Quality, has developed a Quality Management System in compliance with ISO 13485 requirements.

Your role

Under the responsibility of the Head of Innovation QMS, the mission of the QMS Engineer is to participle to the development of this QMS within Innovation department and ensure its global compliance and its relevancy across the different entities of GLI (expertises or/and geographic locations).

This person will also:

- animate the continuous improvement of this QMS and evaluate its performance through the different KPI defined with the process owners.

- oversee the compliance of the QMS with the requirements from ISO 13485 and any others local regulations applicable to GLI activities (21 CFR 820.30, HBRA, NMPA…).

Main responsibilities:

• Animate the GLI QMS from the process description by the process owners in expertise until the measurements of its effectiveness through audit
• Support GLI Process owner for the description of processes (Process description, SOP, WI...) and be a force of proposal for the improvement of these
• Support Innovation QMS Team for the external and Internal Audit

Main requirements:

• Educational Background: Master’s degrees in sciences (Physics, Material…) with specialty in Quality
• First experience in Quality Management System and/or Medical Device industry
• First experience in Medical Device (at least 2 years), Innovation or Quality Management System (including the audit part)
• Solid knowledges in the medical device regulation (MDR 2017/745, 21 CR 820, NMPA…)
• Strong softs skills to animate meeting / training
• Solid soft skills to be synthetic and clear in the communication (oral and written)