QA Specialist, Medical Devices (ISO 13485/MDR)

EssilorLuxottica; Funo di Argelato; Vor Ort; EUR 30.000 - 35.000; Vollzeit

Zusammenfassung

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

You will collaborate with Production, R&D, Regulatory Affairs and suppliers in a dynamic cross‑functional environment, drafting procedures, managing CAPAs, audits, and changes to sustain quality throughout the organization.

Qualifikationen

• Degree in a scientific, engineering, or related field.
• Preferably 1–3 years of experience in Quality Assurance within medical devices.
• 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.

Aufgaben

• Support the maintenance and improvement of the Quality Management System per ISO 13485 and MDR.
• Draft, update, and review procedures, work instructions, forms, and QMS records.
• Support management of changes affecting the QMS and company processes.
• Support internal and third‑party audits.
• Support management of non‑conformities, CAPAs, quality complaints, including root cause analysis.
• Support supplier quality activities including supplier qualification, audits, and corrective actions.
• Support QA activities related to manufacturing and servicing, ensuring process compliance.

Kenntnisse

English proficiency

IT literacy

Ausbildung

Degree in scientific/engineering field

Jobbeschreibung

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

You will collaborate with Production, R&D, Regulatory Affairs and suppliers in a dynamic cross‑functional environment, drafting procedures, managing CAPAs, audits, and changes to sustain quality throughout the organization.