Quality Management System Support

6 mesi fa

Bussolengo, Italia Orthofix A tempo pieno

We offer an interesting opportunity to join our Quality Management System team, based in Bussolengo (VR) a Quality Management System Support, reporting to the Quality Management System Supervisor.

You will be part of Quality Team and it contributes to maintain live and in compliance the Quality Management System implemented in European Subsidiaries.

You will 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.
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, 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 or those of other Bodies; implement Best Practices and plan for continuous Quality System 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.
- Support QMS manager to define and document Quality specifications.
- 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 Organization.
- Ensure quality trainings on new hires and for trainable documents.
- Support QMS manager to coordinate and promote, define, achieve, and maintain the Quality Objectives in collaboration with the Management and with all departments.
- Define and maintain the designated Group Companies’ QMS and relevant documentation (including QM, SOPs, DHF, Traceability records, etc;)
- Support QMS manager to address third party audits.
- Support QMS manager to collect, evaluate and analyze Quality records, report periodically to management on quality issues, trends and losses.
- Evaluate the Quality results achieved and notify to QMS manager any incompatibility with company objectives;
- Promote internal training on quality matters in cooperation with all other functions;
- Promotion and participation in continuous (breakthrough) processes
- Support QMS manager to develop and implement Quality Policies and procedures with regards to 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 team and autonomously.
- Accountability for the assigned tasks
- Travels needed 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

  • Capa Supervisor

    2 settimane fa

    Bussolengo, Italia Orthofix A tempo pieno

    **Quality Compliance Engineer** We offer an interesting opportunity to join our **Quality & Regulatory**team, based in Bussolengo (VR) as a **Quality Compliance Engineer**, reporting to the Senior Quality Compliance Manager, on a temporary contract of one year. In this position you will cooperate with Quality Assurance team to ensure that the Orthofix...

  • Quality Engineering Manager

    7 mesi fa

    Bussolengo, Italia Orthofix A tempo pieno

    We offer an interesting opportunity to join our Quality Engineering team, based in Bussolengo (VR) a Quality Engineering Manager, reporting to the Quality Director Europe. Quality Engineering is the liaison between Quality Assurance Area, Design & Development Area and Regulatory Affairs Area during the Design & Development phase of products. It must...

  • Capa Supervisor

    6 giorni fa

    Bussolengo, Italia Orthofix A tempo pieno

    We are looking for a person to insert as CAPA Supervisor to join our Quality Compliance Department based in Bussolengo (VR). He/She aims cooperate with Quality Assurance team to ensure that the Orthofix Quality System conforms with all reference standards and regulatory requirements (ISO 13485, FDA QSRs, RDC 59/2000 etc.) and that supplied products are fit...

  • Management Assistant

    7 mesi fa

    Bussolengo, Italia Onesails International srl A tempo pieno

    Help on projects management Help on social media management boat shows coordination sail loft relations DB management Translations Contratto di lavoro: Tempo indeterminato, Contratto con partita IVA, Collaborazione Stipendio: €700,00 - €1.400,00 al mese Benefit: - Lavoro da casa - Orario flessibile - Parcheggio libero - Supporto allo sviluppo...

  • Quality Complaints Analyst

    7 mesi fa

    Bussolengo, Italia Orthofix A tempo pieno

    We offer an interesting opportunity to join our Quality Compliance team, based in Bussolengo (VR) a Quality Compliants Analyst, reporting to the Quality Compliance Manager. In this role, you can evaluate, investigate, and resolve complaints while also analyzing complaint data and gathering additional information as needed. You will manage the complaint...

  • Business Process Automation Manager

    3 mesi fa

    Bussolengo, Italia Orthofix A tempo pieno

    We are looking for a **Business Process Automation Manager** to join our IT Team based in Bussolengo (VR). The person will report to the Senior IT Manager Intl and to them will report a team of 3 people. This role interacts with all Italian Departments and with International/US teams and with external suppliers and consultants. **What will your...

  • Design Assurance Engineer

    4 settimane fa

    Bussolengo, Italia Orthofix A tempo pieno

    We are looking for a Design Assurance Engineer, to join our Quality & Regulatory Department, based in Bussolengo (Verona).Position Summary: The role is the liaison between Research & Development (R&D), Process Engineering and Quality Operation areas, and Regulatory Affairs area, during the Design & Development of new products and during business as usual...

  • International Regulatory Specialist

    4 mesi fa

    Bussolengo, Italia Orthofix A tempo pieno

    We offer an interesting opportunity to join our **Regulatory Affairs **team, based in Bussolengo (VR) as **International Regulatory Specialist**, reporting to the Regulatory Affairs Manager. This position ensures that global product international regulatory submissions activities are completed in a timely manner so that full compliance with all applicable...

  • Amministratore di Progetti

    3 settimane fa

    Bussolengo, Veneto, Italia Planetel A tempo pieno

    Descrizione del LavoroIn Planetel, siamo alla ricerca di un professionista con esperienza pluriennale nella vendita di soluzioni ICT e Value Added Services. Il candidato ideale possiede capacità di organizzare e gestire in autonomia il proprio lavoro, elevata capacità di negoziazione e disponibilità a trasferte.Compiti PrincipaliGestire la vendita di...

  • Legal Generalist

    7 mesi fa

    Bussolengo, Italia Orthofix A tempo pieno

    We offer an interesting opportunity to join our Legal team, based in Bussolengo (VR) a Legal Generalist, reporting to the Legal Manager International. He/she is primarily responsible for supporting the Manager in the International Company’s legal activities. This includes helping to prepare and process types of external agreements, sales agreements with...

  • Design Assurance Engineer

    2 mesi fa

    Bussolengo (VR), Italia Orthofix A tempo pieno

    We are looking for a Design Assurance Engineer, to join our Quality & Regulatory Department, based in Bussolengo (Verona). Position Summary: The role is the liaison between Research & Development (R&D), Process Engineering and Quality Operation areas, and Regulatory Affairs area, during the Design & Development of new products and during business as usual...

  • Field Application Engineer

    1 mese fa

    Bussolengo, Italia Panasonic Automotive Systems Europe A tempo pieno

    WHAT YOU WILL BE DOINGField application Engineer in the North East Italy sales region for the automation market (PLC, HMI, networking; servodrives and brushless motors; photoelectric sensors).Support existing customers on site (basic configuration of installations, software training, programming support).Apply deep analytical thinking and problem solving,...

  • Product Regulatory Affairs Specialist- Maternity

    7 mesi fa

    Bussolengo, Italia Orthofix A tempo pieno

    We offer an interesting opportunity to join our Regulatory Affairs team, based in Bussolengo (VR) a Product Regulatory Affairs Specialist, reporting to the Regulatory Affairs Manager. The Product RA Specialist is mainly responsible to assure availability of Technical Documentation File by preparing and maintain up to date the regulatory Product Application...

  • Addetto/a Alle Operazioni Ausiliarie Alla Vendita

    6 mesi fa

    Bussolengo, Italia GIGROUP A tempo pieno

    Ti piacerebbe lavorare all’interno della Grande Distribuzione Organizzata? Gi Group, prima Agenzia per il Lavoro Italiana con oltre 200 filiali sul territorio nazionale e più di 1800 professionisti nel settore delle Risorse Umane, ricerca per nota azienda GDO un/una ADDETTO/A ALLE OPERAZIONI AUSILIARIE ALLA VENDITA - ORTOFRUTTA - BANCO PANETTERIA -...

  • Testing Coordinator

    7 mesi fa

    Bussolengo, Italia Orthofix A tempo pieno

    Testing coordinator We offer an interesting opportunity to join our R&D team, based in Bussolengo (VR) as Testing coordinator reporting to the Software & Electronics Development Manager. In this position, you are responsible for structuring and overseeing the overall testing activities for software solutions, covering the whole product development...

  • Clinical Program Manager

    4 giorni fa

    Bussolengo, Italia Orthofix A tempo pieno

    We are looking for a Clinical Program Manager, to join our Clinical Affairs Team based in Bussolengo (Verona). Position Summary: The Clinical Program Manager (CPM) will report to the Clinical Affairs Manager. He will be working in the Clinical Affairs Department that is responsible for setting-up and managing clinical studies as well as providing general...

  • Field Application Engineer

    1 mese fa

    Bussolengo (VR), Italia Panasonic Automotive Systems Europe A tempo pieno

    WHAT YOU WILL BE DOING Field application Engineer in the North East Italy sales region for the automation market (PLC, HMI, networking; servodrives and brushless motors; photoelectric sensors). Support existing customers on site (basic configuration of installations, software training, programming support). Apply deep analytical thinking and problem...