Quality System Specialist

Experteer Italy; Rolo; In loco; EUR 40.000 - 60.000; Tempo pieno

Descrizione del lavoro

A global healthcare technology company in Rolo, Italy is seeking a Quality Systems Specialist to ensure compliance within the distribution processes. The ideal candidate should have a Bachelor's degree and at least two years of experience in a regulated environment. Strong knowledge of ISO standards and excellent communication skills in Italian and English are essential. This position offers competitive salary and benefits, emphasizing value for employees.

Servizi

Competitive salary

Flexible benefits package

Short-term incentive plan

Competenze

• 2+ years of relevant work experience in a highly regulated environment.
• Experience with ISO9001 - ISO13485 standards.
• Command of Italian and English languages.

Mansioni

• Act as the first point of contact on quality topics.
• Support stakeholders in process implementation and quality improvement.
• Manage ISO certification activities for ISO 13485:2016.
• Drive actions using Key Performance Indicators for continuous improvements.
• Perform internal audits and Gemba Walks for compliance.
• Increase awareness on quality topics within the organization.

Conoscenze

ISO standards knowledge

Communication skills

Collaboration skills

Formazione

Bachelor's degree in engineering, business management, or similar

Master's degree in Engineering, Business Management, or similar

Descrizione del lavoro

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

A Day in the Life

Join Medtronic as a Quality Systems Specialist, based in Rolo, Italy and be part of a company dedicated to enhancing people's lives. In this role you will be responsible for ensuring overall implementation of the Quality Management System and compliance within distribution (internal Medtronic and supplier managed).

Medtronic is committed to revolutionizing healthcare to meet the diverse needs of people worldwide. Together, we accelerate the advancement of meaningful innovations, but our success hinges on assembling the right individuals for our team. This is your perfect opportunity to join us and contribute to our mission of engineering the extraordinary.

Responsibilities may include the following and other duties may be assigned:

• First point of contact on quality topics for processes performed in the local distribution center.
• Support local stakeholders by building quality knowledge, support detailed process implementation, and use project management / quality tools for continuous improvement of processes.
• Manage ISO (International Organization for Standardization) certification activities for the applicable ISO 13485:2016 and provide expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.
• Use Key Performance Indicators to drive actions and continuous improvement initiatives.
• Perform internal audits or Gemba Walks to verify process implementation and compliance, working together with operational teams to drive continuous improvement.
• Increase awareness on Quality topics and embed a Quality mindset in the organization to put patients first.

Required Knowledge and Experience:

• Bachelor's degree in engineering, business management, or similar.
• Min 2 years of relevant work experience in a highly regulated environment (for example: Pharmaceutical, Medical Technology, Automotive or in a Logistical operational environment).
• Knowledge and experience with ISO standards (ISO9001 - ISO 13485).
• Good communication and collaboration skills.
• Command of the Italian and English language both verbal and written.

Desirable would be Master's degree in Engineering, Business Management, or similar.

Also experience in the Medical Device or Pharmaceutical industries would be beneficial.

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.

Benefits & Compensation

Medtronic offers a competitive Salary and flexible Benefits Package.

A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

About 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 95,000+ passionate people.

We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.