QA Specialist, Medical Devices | ISO 13485 & MDR

EssilorLuxottica; Argelato; Sur place; EUR 42 000 - 64 000; Plein temps

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Quality Assurance

ISO 13485 knowledge

English proficiency

Regulatory compliance

Audits knowledge

Formation

Degree in science or engineering

Related field degree

Description du poste

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.