PI-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. /ppReporting directly to the CEO, the candidate will be responsible for: /polliEnsuring application of the Quality Manual in line with ISO 13485 MDSAP, CFR 21 Part 820.20.3 FDA, and MDR SOR 98-282 requirements. /liliPlanning quality improvement programs in collaboration with all company functions. /liliPreparing specific control and Quality Assurance programs for all processes and functions. /liliPromoting and managing corrective actions to prevent recurrence of non-conformities, both internal and external (suppliers), assessing their implementation. /liliProviding methodological support to the commercial area for supplier evaluation, ensuring necessary technical documentation. /liliCollaborating with After-sales and Assembly Manager regarding customer complaints. /liliManaging relations with external entities, clients, and suppliers concerning Quality Guarantee issues. /liliPromoting training programs on Quality topics in line with personnel responsible and company strategies. /liliMaintaining an up-to-date archive of all documentation required by applicable regulations. /liliSupervising internal maintenance of equipment. /liliManaging maintenance performed by external suppliers. /liliManaging calibration of measurement instruments affecting product quality. /liliManaging internal audits. /liliMaintaining certifications. /liliManaging communications with authorities and notified bodies for product and system certification maintenance. /liliOverseeing quality control and safety activities of company devices. /liliReporting anomalies and non-conformities found during final acceptance checks. /liliCollaborating with production lines on non-conforming products and process improvements. /liliFluent knowledge of English and at least 4 years of experience in similar contexts. /liliKnowledge of specific regulations for medical devices (CE, CEI, UNI). /liliUnderstanding of certifications MDR 2017 / 745, UNI EN 13485:2021, ISO 9001:2015, MDSAP, CFR 21 Part 820 FDA, MDR SOR 98-282. /liliKnowledge of technical files related to Medical Devices. /li /olpuNice to have: /u experience in regulatory affairs. /ppbWork location: Granarolo (Bologna) /b /ppOnly 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. /p #J-18808-Ljbffr