QA Specialist

EssilorLuxottica; Argelato; On-site; EUR 42,000 - 64,000; Full time

Job summary

EssilorLuxottica is seeking a QA Specialist to join the Quality & Regulatory Affairs team. The role focuses on maintaining and continuously improving the Quality Management System to ensure compliance with ISO 13485 and MDR across the product lifecycle.

You will collaborate with Production, R&D, Regulatory Affairs, and suppliers to support audits, CAPAs, non-conformities, and documentation control, driving quality improvements in a dynamic environment.

Qualifications

• Degree in a scientific, engineering, or related field.
• Preferably 1–3 years of experience in Quality Assurance within the medical device industry.
• Knowledge of ISO 13485.
• Basic knowledge of Regulation (EU) 2017/745 (MDR).
• Familiarity with non-conformities, CAPA, Change Control, supplier management, audits, and document control.
• Good written and spoken English.
• Good IT skills and ability to manage technical and quality documentation.

Responsibilities

• Support the maintenance and continuous improvement of the Quality Management System in accordance with ISO 13485, MDSAP and applicable regulatory requirements.
• Draft, update, and review procedures, work instructions, forms, and QMS records.
• Support the management of changes affecting the Quality Management System and company processes.
• Support internal and third-party audits
• Support the management of non-conformities, CAPAs and quality-related complaints, including root cause analysis, corrective actions and trend identification.
• Support supplier quality activities, including supplier qualification and monitoring, audits, non-conformity management and corrective actions
• Support Quality Assurance activities related to manufacturing and servicing, including the management of quality issues and compliance of related processes and records.

Skills

Quality Assurance

ISO 13485 knowledge

English proficiency

Regulatory compliance

Audits knowledge

Education

Degree in science or engineering

Related field degree

Job description

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, Oliver Peoples, Vogue Eyewear and Costa), as well as a network that offers consumers high-quality vision care and best-in-class shopping experiences (such as Sunglass Hut, LensCrafters, Salmoiraghi & Viganò and the GrandVision network), and leading e-commerce platforms.

Join our global community of over 190,000 dedicated employees around the world in driving the transformation of the eyewear and eyecare industry.

Your #FutureInSight with EssilorLuxottica

Are you willing to pioneer new frontiers, foster inclusivity and collaboration, embrace agility, ignite passion, and make a positive impact on the world? Join us in redefining the boundaries of what’s possible.

Your role

We are looking for a QA Specialist who will join the Quality & Regulatory Affairs team and support the maintenance and continuous improvement of the company's Quality Management System, ensuring compliance with applicable medical device requirements and contributing to Quality Assurance activities throughout the entire product lifecycle.

The role requires the ability to work in a dynamic, cross-functional environment, collaborating closely with Production, R&D, Regulatory Affairs, and external suppliers.

Main responsibilities:

• Support the maintenance and continuous improvement of the Quality Management System in accordance with ISO 13485, MDSAP and applicable regulatory requirements
• Draft, update, and review procedures, work instructions, forms, and QMS records.
• Support the management of changes affecting the Quality Management System and company processes.
• Support internal and third-party audits
• Support the management of non-conformities, CAPAs and quality-related complaints, including root cause analysis, corrective actions and trend identification.
• Support supplier quality activities, including supplier qualification and monitoring, audits, non-conformity management and corrective actions
• Support Quality Assurance activities related to manufacturing and servicing, including the management of quality issues and compliance of related processes and records.

Main requirements:

• Degree in a scientific, engineering, or related field.
• Preferably 1-3 years of experience in Quality Assurance within the medical device industry
• Knowledge of ISO 13485.
• Basic knowledge of Regulation (EU) 2017/745 (MDR).
• Familiarity with processes such as non-conformities, CAPA, Change Control, supplier management, audits, and document control.
• Good written and spoken English.
• Good IT skills and ability to manage technical and quality documentation.

The following will be considered an advantage:

• knowledge of MDSAP
• experience with electromedical device
• experience with third party, internal and/or supplier audits.

Our Diversity, Equity and Inclusion commitment

We are committed to creating an inclusive environment for all employees. We celebrate diversity and provide equal opportunities to all, regardless of race, gender, ethnicity, religion, disability, sexual orientation, or any other characteristic that makes us unique.