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We offer an interesting opportunity to join our Quality team, based in Verona as a Quality System Manager, reporting to the Quality Director.Quality System Manager (QSM) is part of the Quality Team and it contributes to maintaining live and in compliance with the Quality Management System implemented in Verona and European Subsidiaries. QSM aims to ensure that the OF Quality System conforms with all reference standards and regulatory requirements (MDSAP, ISO 13485, 21 CFR 820...) and that supplied products are fit for their purpose and meet customer expectations. QSM coordinates the activities required to fulfill this aim.Moreover, the QSM monitors and reports on how the quality management system is performing and publishes data and reports regarding company performance against set indicators.QSM liaises with managers and staff internally to ensure the proper functioning of the Quality system. Where appropriate, the QSM 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, QSM must place quality assurance at the heart of his/her responsibilities within the CompanyThe QSM is responsible for coordinating all of the quality system-related activities within the Quality department in support of the Quality mission to improve the quality of productsthrough focused process improvement. This position must ensure QS compliance with company quality system requirements as well as applicable standards and regulations. What will your contribution be?Assure and support the maintenance and continuous improvement of the local and European Subs Quality Management System processes.Assure and support the implementation of Orthofix Global Quality System processes, including but not limited to CAPA, complaint handling, audit, and training.Prepare reports by collecting, analyzing, and summarizing data regarding quality processes/product capabilities, problems and trends, and quality-related design development topicsAssure the proper management of CAPA process Support the area during the Corrective Action/Preventive Action processProactively promote an effective and timely resolution to quality problems with a focus on the true root cause and verified corrective action.Provide support and participate in the validation activities for Quality System software applications.Ensure the proper manaement and execution of the internal audits aligned to the planEnsure the management of the 3rd parties audit activities (pre-audit planning, audit execution and evaluation, and post-audit follow-up and recommendations)Participate in external audits with ISO Registrar, Authorized Representative, and other government agencies.Review and recommend improvements to the implemented Quality Management System (Quality Manual, Standard Operating Procedures, and Work Instructions).Collect process metrics and lessons learned, review and evaluate processes, and work products, and recommend improvements as appropriate.Review documents on ECOs to ensure that the Quality System remains in compliance with all applicable laws and standards and that the system is as efficient and effective, as possible.Ensure the completion of the quality training activities. Establish and monitor the refreshing training activities.Ensure the maintenance of the Quality Management System in European Subsidiaries.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 Systems improvements projects with specific deployed tasks.Maintain the adequacy of QMS Procedures and Operative Procedures, and that these are observed by all employees in the designated Group Companies.Inter-functional support to implement and formalize the design change and all other Quality modifications introduced in the Organization.Ensure the maintenance of controlled documents for their whole lifecycle.Ensure quality training on new hires and for trainable documents.In cooperation with Quality Engineering, establish the product labelWhat are we looking for?Degree or master’s degree.5 years in similar positions, in multinational companies preferably operating in the Medical Device or pharmaceutical field.Fluent in English, both written and oralMethodical, critical thinking and analytical approach to resolve complex issues.Ability to work precisely according to procedures, rules, and regulationsAdherence to timelines and result-oriented attitudeAbility to work in team and autonomously.Accountability for the assigned tasksGood knowledge and understanding of the standard SWAdditional experience, skills, knowledge and/or abilitiesKnowledge of internet investigation for new and updated standards.Experience with global audits such as with Brazil and Japan.Systems engineering a strong plus.An aptitude for Quality and Regulatory Compliance.What soft skills will you improve?PrecisionAccountabilityProblem SolvingCommunication skillsWhat will you find?Friendly, warm, and innovative atmosphereHealthy, inspiring, and international and inclusive work environmenttraining and development opportunitiesSmart working model (two days per week)Competitive reward packagesAnnual bonus planSocial and company eventsWellbeing initiatives (welfare..)CanteenWelfareBenefits (Pension Fund- Health Insurance)What we offer?This is a full-time jobThe contract is a permanent contractSalary package range : 55.000/60.000 euroDo you want to join us? Are you ready to make the difference? We look forward to your application. Please send it to careers@orthofix.com