QA Specialist: Medical Devices, ISO 13485 & CAPA Expert

EssilorLuxottica; Emilia-Romagna; On-site; EUR 30,000 - 35,000; Full time

Job summary

EssilorLuxottica is seeking a QA Specialist to join the Quality & Regulatory Affairs team. The role focuses on maintaining the Quality Management System and ensuring compliance with medical device requirements throughout the product lifecycle.

You will collaborate with Production, R&D, Regulatory Affairs, and external suppliers to support audits, non-conformities, CAPAs, and supplier quality activities. Strong English and documentation skills are essential.

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.
• Familiarity with Regulation (EU) 2017/745 (MDR).
• Good written and spoken English.
• Good IT skills and ability to manage technical and quality documentation.

Responsibilities

• Maintain and improve 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

English

Education

Bachelor's degree in science/engineering

Tools

CAPA process

Change Control

Audit management

Job description

EssilorLuxottica is seeking a QA Specialist to join the Quality & Regulatory Affairs team. The role focuses on maintaining the Quality Management System and ensuring compliance with medical device requirements throughout the product lifecycle.

You will collaborate with Production, R&D, Regulatory Affairs, and external suppliers to support audits, non-conformities, CAPAs, and supplier quality activities. Strong English and documentation skills are essential.