QA Specialist – Medical Devices (ISO 13485) | Impact & Growth

EssilorLuxottica; Funo di Argelato; On-site; EUR 30,000 - 35,000; Full time

Job summary

EssilorLuxottica in Italy is seeking a QA Specialist to join the Quality & Regulatory Affairs team and support the upkeep and continuous improvement of the QMS, ensuring compliance with ISO 13485 and MDR requirements across the product lifecycle.

The role involves cross-functional collaboration with Production, R&D, Regulatory Affairs and suppliers, handling CAPAs, non-conformities, audits, and quality records to drive compliance and excellence.

Qualifications

• Degree in a scientific, engineering, or related field.
• 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

English proficiency

Education

Degree in a scientific, engineering, or related field

Job description

EssilorLuxottica in Italy is seeking a QA Specialist to join the Quality & Regulatory Affairs team and support the upkeep and continuous improvement of the QMS, ensuring compliance with ISO 13485 and MDR requirements across the product lifecycle.

The role involves cross-functional collaboration with Production, R&D, Regulatory Affairs and suppliers, handling CAPAs, non-conformities, audits, and quality records to drive compliance and excellence.