Callegari S.r.l., a company based in Parma (PR) specializing in the design and production of electromedical and aesthetic devices, is looking for:

1 Quality Assurance Specialist for the technical department

The successful candidate will join the Quality and Regulatory team and will be responsible for supporting the maintenance of the Quality Management System (QMS) in accordance with ISO 9001, ISO 13485, and Regulation 2017/746 (IVDR).

The QA Specialist will be responsible for:

• Ensure the Quality System is effectively implemented in accordance with ISO 13485 and internal procedures, and ensure that the finished product is released in compliance with mandatory requirements;

• Create and update Quality Management System documentation;

• Manage and monitor the progress of non-conformities and CAPA plans;

• Analyze complaints with the relevant departments to maintain Quality Management System compliance;

• Assist in the management of process validations.

• Collaborate on the qualification process and periodic performance monitoring of suppliers to ensure high quality standards.

• Participate in and assist with the management of internal and external audits conducted in accordance with relevant standards (ISO 13485, CE Marking).

• Collect, analyze, and monitor KPIs.

Preferred Qualifications

• At least 3 years of experience in a medical device manufacturing company (preferably electromedical devices).

• Experience in Quality Management System administration in accordance with ISO 13485.

• Good knowledge of Regulation 2017/746 (IVDR).

• Excellent command of the English language.

• Advanced proficiency in MS Office (Excel, Word, PowerPoint).

• Excellent interpersonal and teamwork skills, proactivity, curiosity, a methodical approach, and strong organizational and problem-solving abilities are required.

• A degree in scientific or technical disciplines is preferred.

Work location

Via Luigi Natale Vernazzi 13/A, 43122 Parma

Full-time

‍9:00 AM – 1:00 PM / 2:00 PM – 6:00 PM

If you are interested, please send your CV to the following address: job@catellanigroup.com.

By applying, you provide specific consent for the use of your personal data in accordance with EU Regulation 2016/679. This job posting is open to all genders (Art. 27, paragraph 5, Legislative Decree 198/06).