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.

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.

Support the preparation, revision, implementation, and release of Quality Management System procedures.
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.
Contribute to the integration and continuous improvement of Quality System documentation to ensure compliance with EU MDR 2017⁄745 .

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 certification is considered a strong advantage.

Flexibility and adaptability
Level between D1 and C2 of the “Industria-Chimica” CCNL - with a RAL ranging between 34.000€ & 36.000€

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📌 Quality Specialist (Italia)
🏢 Cid
📍 Italia