Quality Assurance Specialist

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7fnf6p

We are a global developer and manufacturer of interventional medical devices in the fields of endovascular and interventional cardiology. We manufacture our products entirely in-house, from raw materials to finished goods, and distribute them worldwide through our direct sales force and network of distributors.

We are looking for a tempo pieno QA Specialist for our Italian headquarters to join an already structured team.

Role Purpose:
Reporting directly to the QA Manager , you will play a key role in maintaining and improving the Quality Management System, ensuring compliance with ISO 13485 and EU MDR 2017⁄745 . You will collaborate closely with cross-functional teams to support quality processes and regulatory requirements.

Key Responsibilities
- Support the preparation, revision, implementation, and release of Quality Management System procedures.
- Participate in internal and external auditing activities.
- Manage Product Change Control and CAPA (Corrective and Preventive Actions) processes.




- Prepare validation protocols and reports for cleanroom qualification and validation activities.
- Support the QA Manager with Quality System activities, including the preparation of Management Reviews .
- Perform trend analyses in collaboration with the Clinical team to support complaint management.
- Prepare and maintain usability documentation.
- Contribute to the integration and continuous improvement of Quality System documentation to ensure compliance with EU MDR 2017⁄745 .

Qualifications
- Bachelor’s degree or equivalent background in a relevant scientific or technical field.
- At least 3 years of experience in a Quality Assurance role within a structured organization, preferably in the medical device or another regulated industry.
- Good knowledge of ISO 13485 and EU MDR 2017⁄745 .
- Understanding of Quality Management Systems and auditing processes.
- Experience participating in internal and/or external audits.
- Fluent English (written and spoken).
- Auditor cert

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7fnf6p