Requirements: English
Company: Orthofix
Region: Verona , Veneto
We offer an interesting opportunity to join our Quality team, based in Bussolengo (VR) as Quality Management System Specialist, reporting to the Director, Quality - Europe, on a full time permanent contract.
In this position you will contributes to maintaining 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. You will also monitor and reports on how the quality management system is performing and publishes data and reports regarding company performance against set indicators.
Responsibilities include liaises with managers and staff internally to ensure the proper functioning of the Quality system. Where appropriate, you will report 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.
This position must deal with other company departments and international 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 Quality Management System in compliance with applicable standards.
- Ensure the maintenance of the 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.
- Ensure the maintenance of controlled documents for their whole lifecycle.
- Coordinate the management of product modifications in cooperation with the Organization.
- Ensure quality training on new hires and for trainable documents.
- Support or manage the implementation of the CAPA (Corrective and Preventive Action).
- Support or manage the preparation, execution, and reporting of the internal audit activities respecting the plan established.
- Support QAS to collect, evaluate and analyze Quality records; report periodically to management on corrective and preventive action.
What are we looking for?
- Preferred technical degree or masters degree
- 2 years in similar positions, in multinational companies preferably operating in the Medical Device field.
- Internal auditor qualification welcome
- Excellent English written and spoken required
- Good knowledge of Microsoft office and with analysis and reporting tools
What soft skills will you improve?
- Ability to work precisely according to procedures, rules, and regulations
- Adherence to timelines and result 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
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
- 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