Quality Systems Specialist
5 mesi fa
**Careers That Change Lives**
In this exciting role as Quality Systems Specialist, you will be responsible for Quality activities within the Italian Medtronic Sales office, which is responsible for compliant selling, customer education, order management and distribution of the full Medtronic product portfolio.
You will be reporting to the manager of the Europe, Middle East and Africa (EMEA) Quality Compliance Team Western Europe. The EMEA Quality organization is an engaged team which ensures patient safety and facilitates patient access to Medtronic therapies through reliable execution, by driving and transforming preventive & innovative processes and by being a valued partner to our internal and external stakeholders.
**A Day in the Life**
As Quality Systems Specialist your main responsibilities will be:
- Leading ongoing implementation of the EMEA Quality Management System to ensure compliance to ISO 13485:2016/ISO 9001:2015 and internal standards, and to achieve Quality performance against the established key performance indicators.
- Establishing, documenting, implementing and maintaining processes to meet local regulatory and/or governmental regulations.
- Working directly together with local stakeholders like Sales & Marketing, Customer Service, Finance, Legal and HR to enhance Quality awareness, and to provide guidance on the execution of Quality processes to meet compliance.
- Preparing Quality meetings with senior management, monitoring Quality performance based on key performance indicators and sharing with applicable stakeholders.
- Ensuring the necessary quality controls for suppliers and distributors.
- Leading audit and inspection preparation, resolution of findings and liaising with auditing groups and inspectors through all stages of the audits.
- Identifying and follow-up on opportunities for improvements, corrective & preventive actions (CAPA) and process enhancements.
- Liaising with stakeholders within EMEA Global Regions Quality to facilitate uniform standards and to enable best practice sharing.
**Must Haves**
- Bachelor degree
- 2-3 years of experience in Quality in a regulated environment
- Being a self-starter, able to work independently
- Good collaboration skills
- Fluent in Italian, good command in English
- Strong written and verbal communication skills
- Knowledge of general software tools like Microsoft OfficeFluent English (as you will enjoy participating into global projects to continuously improve service and, your skills and employability)
**Nice to Haves**
- Experience within the medical device industry
- Knowledge of specific Quality software tools like Agile, Trackwise
**We Offer**
We offer a compensation package including attractive benefits to all our employees:
- Smart working environment
- Annual Incentive Plan % depending on company results
- Multiple training possibilities via Cornerstone/Skills Lab
- Employee Assistance Program and Recognize (Our global recognition program)
- Tailored career pathways to develop yourself as professional in one of the most valuable sectors
**Our Commitment**
Our unwavering commitment to inclusion, diversity, and equity (ID&E) means zero barriers to opportunity within Medtronic and a culture where all employees belong, are respected, and feel valued for who they are and the life experiences they contribute. We know equity starts beyond our workplace, and we must play a role in addressing systemic inequities in our communities if we hope to have long-term sustainable impact.
Anchored in our Mission, we continue to drive ID&E forward both to enhance the well-being of Medtronic employees and to accelerate innovation that brings our lifesaving technologies to more people in more places around the world.
**About Medtronic**
Bold thinking. Bolder actions. We are Medtronic.
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 90,000+ passionate people. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world.
In everything we do, we are **engineering the extraordinary **.
**Your Answer**
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