QUALITY MANAGEMENT SYSTEM SUPPORT

We offer an interesting opportunity to join our Quality Management System team, based in Bussolengo (VR) as a Quality Management System Support, reporting to the Quality Management System Supervisor. You will be part of the Quality Team, contributing to maintaining and ensuring compliance of the Quality Management System implemented in European Subsidiaries. You will ensure that the 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. The QMSS coordinates 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. The QMSS 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, the QMSS must place quality assurance at the heart of his/her responsibilities within the Company. What will your contribution be? Support QMS manager to ensure the maintenance of Quality Management System in compliance with applicable standards. Ensure the maintenance of Quality Management System in European Subsidiaries. Support 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; implement Best Practices and plan for continuous Quality System improvements projects with specific deployed tasks. Maintain the adequacy of QMS Procedures and Operative Procedures, ensuring these are observed by all employees in the designated Group Companies. Support QMS manager to define and document Quality specifications. Provide inter-functional support to implement and formalize the design change and all other Quality modifications introduced in the Organization. Coordinate the management of product modifications in cooperation with the Organization. Ensure quality training for new hires and for trainable documents. Support QMS manager to coordinate and promote, define, achieve, and maintain the Quality Objectives in collaboration with Management and all departments. Define and maintain the designated Group Companies’ QMS and relevant documentation (including QM, SOPs, DHF, Traceability records, etc.). Manage changes to QMS based on amendments to international standards and ensure their correct application. Support QMS manager to address third-party audits. Support QMS manager to collect, evaluate, and analyze Quality records, reporting periodically to management on quality issues, trends, and losses. Evaluate the Quality results achieved and notify the QMS manager of any incompatibility with company objectives. Cooperate with regulatory affairs in the preparation and maintenance of adequate regulatory documents and certifications relevant to medical devices manufactured by Orthofix. Promote internal training on quality matters in cooperation with all other functions. Participate in continuous (breakthrough) processes. Support QMS manager to develop and implement Quality Policies and procedures regarding the definition of the International applicable standards. What are we looking for? Degree or master’s degree 2 years in similar positions in multinational companies, preferably operating in the Medical Device field. Fluency in English Good knowledge of Microsoft Office. What soft skills will you improve? Critical thinking. Ability to work precisely according to procedures, rules, and regulations. Adherence to timelines and result-oriented attitude. Orderliness and attention to detail. Analytical approach to resolve complex issues. Ability to work in a team and autonomously. Accountability for the assigned tasks. Willingness to travel according to specific product/projects. What will you find? Friendly, warm, and innovative atmosphere. Healthy, inspiring, and international and inclusive work environment. Training and development opportunities. Smart working model (two days per week). Competitive reward packages. Annual bonus. Social and company events. Wellbeing initiatives (welfare - yoga classes). Canteen. Benefits (Pension Fund - Health Insurance). What do we offer? This is a full-time job. The contract is permanent. Salary package range: 35,000 - 40,000 euro. #J-18808-Ljbffr