Requirements: English
Company: Orthofix
Region: Bussolengo , Veneto
We offer an interesting opportunity to join ourQuality team, based in Bussolengo (VR) as Quality Management SystemSpecialist, reporting to the Director, Quality - Europe, on a fulltime permanent contract. In this position you will contributes tomaintaining live and in compliance the Quality Management Systemimplemented in European Subsidiaries. You will ensure that the OFQuality System conforms with all reference standards and regulatoryrequirements (ISO 13485, 21 CFR 820...) and that supplied productsare fit for their purpose and meet customer expectations. You willalso monitor and reports on how the quality management system isperforming and publishes data and reports regarding companyperformance against set indicators. Responsibilities includeliaises with managers and staff internally to ensure the properfunctioning of the Quality system. Where appropriate, you willreport on amendments and implements any changes required, andprovides training, tools, and techniques to ensure that qualitystandards are maintained and can be achieved by all competentstaff. This position must deal with other company departments andinternational colleagues. Especially Consultants, Subsidiaries,Competent Authorities, Distributors, External laboratories,suppliers and Notify Body. What will your contribution be? -Support the QMS manager to ensure the maintenance of the QualityManagement System in compliance with applicable standards. - Ensurethe maintenance of the Quality Management System in EuropeanSubsidiaries. - Support QMS manager to ensure that all the Companyprocesses are designed and executed according to policies,predetermined internal procedures, and international applicablestandards such as MDD, MDR, FDA, or those of other Bodies;implement Best Practices and plan for continuous Quality Systemimprovements projects with specific deployed tasks. - Maintain theadequacy of QMS Procedures and Operative Procedures, and that theseare observed by all employees in the designated Group Companies. -Support QMS manager to define and document Quality specifications.- Inter-functional support to implement and formalize the designchange and all other Quality modifications introduced in theOrganization. - Ensure the maintenance of controlled documents fortheir whole lifecycle. - Coordinate the management of productmodifications in cooperation with the Organization. - Ensurequality training on new hires and for trainable documents. -Support or manage the implementation of the CAPA (Corrective andPreventive Action). - Support or manage the preparation, execution,and reporting of the internal audit activities respecting the planestablished. - Support QAS to collect, evaluate and analyze Qualityrecords; report periodically to management on corrective andpreventive action. What are we looking for? - Preferred technicaldegree or masters degree - 2 years in similar positions, inmultinational companies preferably operating in the Medical Devicefield. - Internal auditor qualification welcome - Excellent Englishwritten and spoken required - Good knowledge of Microsoft officeand with analysis and reporting tools What soft skills will youimprove? - Ability to work precisely according to procedures,rules, and regulations - Adherence to timelines and resultresult-oriented attitude - Orderliness and attention to detail -Analytical approach to resolve complex issues. - Ability to work inteam and autonomously. - Accountability for the assigned tasks Whatwill you find? - Friendly, warm, and innovative atmosphere -Healthy, inspiring, and international and inclusive workenvironment - Training and development opportunities - Smartworking model (two days per week) - Competitive reward packages -Social and company events - Wellbeing initiatives (welfare) -Canteen - Benefits (Pension Fund- Health Insurance) What we offer?- This is a full-time job - The contract is a permanent contract -Salary package range: 40.000/45.000 euro