Quality System Specialist

Medtronic; Rolo; In loco; EUR 40.000 - 60.000; Tempo pieno

Descrizione del lavoro

A leading healthcare technology firm based in Rolo, Italy, is seeking a Quality Systems Specialist. In this role, you will manage the Quality Management System and ensure compliance with ISO standards. You will collaborate with local stakeholders and drive continuous improvement initiatives. The ideal candidate holds a Bachelor's degree and has at least 2 years of experience in a regulated setting, with strong communication skills in both Italian and English.

Servizi

Competitive salary

Flexible benefits package

Competenze

• Minimum 2 years of relevant work experience in a regulated environment.
• Experience managing ISO certification activities.
• Fluent in Italian and English, both verbal and written.

Mansioni

• Act as the first point of contact on quality topics.
• Support stakeholders in quality knowledge and process implementation.
• Perform internal audits to verify compliance.

Conoscenze

ISO standards knowledge

Communication skills

Collaboration skills

Formazione

Bachelor's degree in engineering or business management

Descrizione del lavoro

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.

Overview

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

Responsibilities

• 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).
• Good communication and collaboration skills.
• Command of the Italian and English language both verbal and written.

Desirable

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

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.

Learn more about our business, mission, and our commitment to diversity here