We offer an interesting opportunity to join our Quality Management team, based in Verona as a Quality System Engineer Supervisor, reporting to the Manager of Quality System Area.
This position plays a pivotal role in ensuring the Quality Management System remains active and compliant across Verona and the European subsidiaries. The individual in this role will be responsible for coordinating all quality system activities within the Quality department, supporting the mission to enhance product quality through targeted process improvements. This includes meeting quality system requirements and adhering to relevant standards and regulations.
This position will interact with various company departments and international colleagues, including Consultants, Subsidiaries, Competent Authorities, Notified Bodies, Distributors, External laboratories, and suppliers.
International and domestic travel is required for 10%-20% according to business needs.
What will your contribution be? Support the maintenance and continuous improvement of the local and European Subs Quality Management System processes. 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 topics. Support the area during the Corrective Action/Preventive Action process. Proactively 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. Support the area during the 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. Ensure that all applicable external standards, both systemic and product-specific, are up to date, available for use, and properly implemented. 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. Support the 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 Systems improvements projects with specific deployed tasks. Support manager to define and document Quality specifications. In cooperation with Quality Engineering, establish the product label. What 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 oral. Methodical, critical thinking and analytical approach to resolve complex issues. Ability to work precisely according to procedures, rules, and regulations. Adherence to timelines and result-oriented attitude. Ability to work in a team and autonomously. Accountability for the assigned tasks. Good knowledge and understanding of the standard SW. Additional experience, skills, knowledge and/or abilities Knowledge 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? Precision. Accountability. Problem Solving. Communication skills. 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 plan. Social and company events. Wellbeing initiatives. Canteen. Welfare. Benefits (Pension Fund- Health Insurance). What we offer? This is a full-time job. The contract is a permanent contract. Salary package range: 45,000/50,000 euro. Do you want to join us? Are you ready to make the difference? We look forward to your application. Please send it to ******
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