Quality Manager

4 giorni fa

Rome, Italia Hantech Medical A tempo pieno

Overview Hantech Medical ( is specialized in Contract R&D and Manufacturing services of medical consumables and innovation of medical core components. Our products range from interventional catheters and related consumables, infusion and drug delivery system consumables, dental consumables, diabetes treatment consumables and epidemic prevention products. For our site in Villamarzana (Rovigo), Hantech Medical ITALY, we are looking for a QUALITY MANAGER. ResponsibilitiesLead the Quality Operations and Regulatory Affairs departments, defining and overseeing the processes included in the Quality Management System (QMS) and relevant procedures. Monitor the application of these processes throughout the Organization, reviewing performance of the QMS at planned intervals to ensure effectiveness and compliance with applicable requirements. Organize the Management Review at documented planned intervals, collect the input for the review and document the output of the review. Manage supplier qualification processes and monitoring, including the conduction of supplier audit according to the internal procedures. Define adequate Quality Plan to manage the scope extension of QMS (e.g., manufacturing of products different from medical devices, plastic material transformation, etc.) and to manage compliance to additional applicable standards. Provide support to internal stakeholders and corporate Regulatory function, maintaining liaison with Notified Body and regulatory authorities. Act as Management Representative, ensuring that processes needed for the QMS are documented, awareness of applicable regulatory requirements is promoted, and conformity of devices is appropriately checked before a device is released.QualificationsBachelor's degree in a scientific discipline, engineering, pharmacy or another relevant scientific discipline. Minimum 5 years of professional experience in management of Quality Management System, of which 3 years minimum of professional experience relating to medical devices. In-depth knowledge of relevant European regulations and standards, such as ISO 13485:2016, EN ISO 13485:2016/A11:2021 and 21 CFR Part 820 of FDA. Strong project management skills and ability to prioritize and manage multiple projects simultaneously. Excellent understanding of the product development process and ability to apply regulatory requirements to each stage. Experience in interacting with Notified Body regulatory authorities/agencies and managing regulatory inspections and audits. Excellent written and verbal communication skills, effectively communicating complex regulatory concepts to both technical and non-technical stakeholders. Strong analytical and problem-solving skills, identifying and resolving regulatory issues effectively. Demonstrated ability to work collaboratively in cross-functional teams and effectively influence stakeholders at all levels.EEO Statement This announcement is addressed to both sexes, in accordance with laws 198/2006, and to people of all ages and all nationalities, pursuant to legislative decrees 215/03 and 216/03. #J-18808-Ljbffr

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