Medical Device QA Specialist — ISO 13485 Focus

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

Job summary

EssilorLuxottica is seeking a QA Specialist to join the Quality & Regulatory Affairs team in Bologna. You will support maintenance and continuous improvement of the Quality Management System, ensuring compliance with medical device requirements across the product lifecycle.

Responsibilities include drafting and reviewing procedures and records, managing changes, supporting audits, handling non-conformities and CAPA activities, and coordinating supplier quality initiatives.

Qualifications

• Degree in a scientific, engineering, or related field.
• 1–3 years QA experience in medical devices preferred.
• Knowledge of ISO 13485.
• Basic knowledge of MDR (EU 2017/745).
• Familiar with non-conformities, CAPA, Change Control, audits.
• Good written and spoken English.
• Strong IT skills and documentation management.

Responsibilities

• Maintain and improve the QMS per ISO 13485, MDSAP, and regulatory requirements.
• Draft, update, and review procedures, work instructions, forms, and QMS records.
• Support changes affecting the QMS and company processes.
• Assist internal and third-party audits.
• Handle non-conformities, CAPA, root-cause analysis, and trend actions.
• Support supplier quality activities: qualifications, audits, and corrective actions.
• Assist QA activities related to manufacturing and servicing.

Education

Degree in a scientific/engineering field

Job description

EssilorLuxottica is seeking a QA Specialist to join the Quality & Regulatory Affairs team in Bologna. You will support maintenance and continuous improvement of the Quality Management System, ensuring compliance with medical device requirements across the product lifecycle.

Responsibilities include drafting and reviewing procedures and records, managing changes, supporting audits, handling non-conformities and CAPA activities, and coordinating supplier quality initiatives.