I-Tech Industries, an international company recognized and certified for research and development, production, and marketing of devices dedicated to the Fitness & Wellness, advanced aesthetics, medical, Spa & Resort sectors, is seeking a Quality Manager for its Bologna headquarters.
Reporting directly to the CEO, the candidate will be responsible for:
* Ensuring application of the Quality Manual in line with ISO 13485 MDSAP, CFR 21 Part 820.20.3 FDA, and MDR SOR 98-282 requirements.
* Planning quality improvement programs in collaboration with all company functions.
* Preparing specific control and Quality Assurance programs for all processes and functions.
* Promoting and managing corrective actions to prevent recurrence of non-conformities, both internal and external (suppliers), assessing their implementation.
* Providing methodological support to the commercial area for supplier evaluation, ensuring necessary technical documentation.
* Collaborating with After-sales and Assembly Manager regarding customer complaints.
* Managing relations with external entities, clients, and suppliers concerning Quality Guarantee issues.
* Promoting training programs on Quality topics in line with personnel responsible and company strategies.
* Maintaining an up-to-date archive of all documentation required by applicable regulations.
* Supervising internal maintenance of equipment.
* Managing maintenance performed by external suppliers.
* Managing calibration of measurement instruments affecting product quality.
* Managing internal audits.
* Maintaining certifications.
* Managing communications with authorities and notified bodies for product and system certification maintenance.
* Overseeing quality control and safety activities of company devices.
* Reporting anomalies and non-conformities found during final acceptance checks.
* Collaborating with production lines on non-conforming products and process improvements.
* Fluent knowledge of English and at least 4 years of experience in similar contexts.
* Knowledge of specific regulations for medical devices (CE, CEI, UNI).
* Understanding of certifications MDR 2017 / 745, UNI EN 13485:2021, ISO 9001:2015, MDSAP, CFR 21 Part 820 FDA, MDR SOR 98-282.
* Knowledge of technical files related to Medical Devices.
Nice to have: experience in regulatory affairs.
Work location: Granarolo (Bologna)
Only CVs with consent to data processing in accordance with EU Regulation 2016/679 (GDPR) and Legislative Decree 101/2018 will be considered. Candidates of all genders (D.lgs. n. 198/2006) are invited to read the Privacy Policy at. Additionally, CVs may be considered for other vacancies and may be managed and communicated through company tools or the client’s tools.
#J-18808-Ljbffr