PWe offer an interesting opportunity to join our Quality team, based in Bussolengo (VR) as Quality Management System Specialist, reporting to the Quality Management System Manager, on a full-time permanent contract. /ppThe person is part of Quality Team and it contributes to maintain live and in compliance the Quality Management System implemented in European Subsidiaries. /ppHe/She aims to ensure that the OF Quality System conforms with all reference standards and regulatory requirements (ISO 13485, 21 CFR 820...) and that supplied products are fit for their purpose and meet customer expectations. QMSS co-ordinates the activities required to fulfill this aim. Moreover, the QMSS monitors and reports on how the quality management system is performing and publishes data and reports regarding company performance against set indicators. /ppQMSS liaises with managers and staff internally to ensure the proper functioning of the Quality system. Where appropriate, the QMSS reports on amendments and implements any changes required, and provides training, tools and techniques to ensure that quality standards are maintained and can be achieved by all competent staff. As maintaining quality demands continuously adapting to meet customer expectations, QMSS must place quality assurance at the heart of his/her responsibilities within the Company. /ppWhat will your contribution be? /pulliSupport QMS manager to ensure the maintenance of Quality Management System in compliance with applicable standards. /liliManages compliance of the training program /liliPerforms or assists in performing internal audits /liliEnsure the maintenance of Quality Management System in European Subsidiaries. /liliSupport QMS manager to ensure that all the Company processes are designed and executed according to policies, predetermined internal procedures and international applicable standards such as MDD, MDR, FDA or those of other Bodies; implement Best Practices and plan for continuous Quality System improvements projects with specific deployed tasks. /liliMaintain the adequacy of QMS Procedures and Operative Procedures, and that these are observed by all employees in the designated Group Companies. /liliSupport QMS manager to define and document Quality specifications. /liliInter-functional support to implement and formalize the design change and all other Quality modifications introduced in the Organization. /liliEnsure the maintenance of controlled documents for their whole lifecycle. /liliCoordinate the management of product modifications in cooperation with Organization. /liliEnsure quality trainings on new hires and for trainable documents. /liliSupport QMS manager to address third party audits; /liliSupport QMS manager to collect, evaluate and analyze Quality records; report periodically to management on quality issues, trends and losses; /liliEvaluate the Quality results achieved and notify to QMS manager any incompatibility with company objectives; /liliCooperate with regulatory affairs in the preparation and maintenance of adequate regulatory documents and certifications relevant to medical devices manufactured by Orthofix and/or in any case placed on the marketplace subject to the control of the related QS (e.g., OEM business); /liliPromote internal training on quality matters in cooperation with all other functions; /liliPromotion and participation in continuous (breakthrough) processes /liliSupport QMS manager to develop and implement Quality Policies and procedures with regards to the definition of the International applicable standard /li /ulpWhat are we looking for? /pulliPreferred technical degree or master’s degree /lili2 years in similar positions, in multinational companies preferably operating in the Medical Device field. /liliInternal auditor qualification welcome /liliExcellent English written and spoken required /liliGood knowledge of Microsoft office and with analysis and reporting tools /li /ulpWhat soft skills will you improve? /pulliAbility to work precisely according to procedures, rules, and regulations /liliAdherence to timelines and result result-oriented attitude /liliOrderliness and attention to detail /liliAnalytical approach to resolve complex issues. /liliAbility to work in team and autonomously. /liliAccountability for the assigned tasks /li /ulpWhat will you find? /pulliFriendly, warm, and innovative atmosphere /liliHealthy, inspiring, and international and inclusive work environment /liliTraining and development opportunities /liliSmart working model (two days per week) /liliCompetitive reward packages /liliSocial and company events /liliWellbeing initiatives (welfare) /liliCanteen /liliBenefits (Pension Fund- Health Insurance) /li /ulpWhat we offer? /pulliThis is a full-time job /liliThe contract is a permanent contract /liliSalary package range: 45.000/50.000 euro* /li /ulp*please note that this is a range; the complete salary package will be defined based on the seniority / skills of the person /ppDo you want to join us? Are you ready to make a difference? /p