We offer an interesting opportunity to join our Quality team, based in Verona as a Quality System Manager, reporting to the Quality Director.
The Quality System Manager (QSM) is part of the Quality Team and contributes to maintaining compliance with the Quality Management System implemented in Verona and European Subsidiaries.
The 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. The 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.
The 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, providing 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, the QSM must place quality assurance at the heart of his/her responsibilities within the company.
The QSM is responsible for coordinating all quality system-related activities within the Quality department in support of the quality mission to improve the quality of products through 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?
1. Assure and support the maintenance and continuous improvement of the local and European Subsidiaries Quality Management System processes.
2. Assure and support the implementation of Orthofix Global Quality System processes, including but not limited to CAPA, complaint handling, audit, and training.
3. Prepare reports by collecting, analyzing, and summarizing data regarding quality processes/product capabilities, problems and trends, and quality-related design & development topics.
4. Assure the proper management of the CAPA process.
5. Support the area during the Corrective Action/Preventive Action process.
6. Proactively promote an effective and timely resolution to quality problems with a focus on the true root cause and verified corrective action.
7. Provide support and participate in the validation activities for Quality System software applications.
8. Ensure the proper management and execution of internal audits aligned to the plan.
9. Ensure the management of the 3rd party audit activities (pre-audit planning, audit execution and evaluation, and post-audit follow-up and recommendations).
10. Participate in external audits with ISO Registrar, Authorized Representative, and other government agencies.
11. Review and recommend improvements to the implemented Quality Management System (Quality Manual, Standard Operating Procedures, and Work Instructions).
12. Collect process metrics and lessons learned, review and evaluate processes and work products, and recommend improvements as appropriate.
13. 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.
14. Ensure the completion of the quality training activities.
15. Establish and monitor the refreshing training activities.
16. Ensure the maintenance of the Quality Management System in European Subsidiaries.
17. Ensure that all 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.
18. Maintain the adequacy of QMS Procedures and Operative Procedures, and ensure that these are observed by all employees in the designated Group Companies.
19. Provide inter-functional support to implement and formalize the design change and all other Quality modifications introduced in the organization.
20. Ensure the maintenance of controlled documents for their whole lifecycle.
21. Ensure quality training on new hires and for trainable documents.
22. 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 software.
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 is a strong plus.
* An aptitude for Quality and Regulatory Compliance.
What soft skills will you improve?
* Precision
* Accountability
* Problem Solving
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.
* 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: 55,000/60,000 euro.
Do you want to join us? Are you ready to make the difference? We look forward to your application. Please send it to careers@orthofix.com.
Seniority level
Associate
Employment type
Contract
Job function
Quality Assurance
Industries
Medical Equipment Manufacturing
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