Quality Assurance Manager

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 https://i-techindustries.com/privacy-policy/ . 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

Location: spilamberto, IT

Posted Date: 6/11/2025