QA Specialist

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

Your role

We are looking for a QA Specialist who will join the Quality & Regulatory Affairs team and support the maintenance and continuous improvement of the company's Quality Management System, ensuring compliance with applicable medical device requirements and contributing to Quality Assurance activities throughout the entire product lifecycle.

Main 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.

Main Requirements

• 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 processes such as 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.

The Following Will Be Considered An Advantage

• knowledge of MDSAP
• experience with electromedical device
• experience with third party, internal and/or supplier audits.

Salary Package

• Annual Gross Salary: 30.000 Eur – 35 .000 Eur

Recruiting process

Our recruitment process may vary; If you are selected, you will be contacted by our recruiters to guide you through the specific steps for your application.

Our Diversity, Equity and Inclusion commitment

We are committed to creating an inclusive environment for all employees. We celebrate diversity and provide equal opportunities to all, regardless of race, gender, ethnicity, religion, disability, sexual orientation, or any other characteristic that makes us unique.