Quality System Specialist

Posted 5 Days Ago
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Heerlen
Junior
Healthtech
The Role
As a Quality Systems Specialist, you will manage ISO certification activities, ensure compliance with quality standards, and drive continuous improvement in distribution processes.
Summary Generated by Built In

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 LifeJoin Medtronic as a Quality Systems Specialist and be a part of a company dedicated to enhancing people's lives. Based in Heerlen, Netherlands, in this role you will be responsible for ensuring overall implementation of the Quality Management System and compliance within distribution.
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 centers.
  • Support process owners 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 and support local organizations on identifying improvement areas.

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 (ISO 9001 / ISO 13485).
  • Good communication and collaboration skills. 
  • Excellent command of the English language both verbal and written, command of the Dutch language 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  
 

Top Skills

Iso 13485
Iso 9001
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The Company
HQ: Minneapolis, MN
80,303 Employees
On-site Workplace

What We Do

Medtronic is a global healthcare solutions company operating in approximately 160 countries. We are committed to improving lives through our medical technologies, services, and solutions.

Since our beginning, 60 years ago, our Mission has remained the same: to alleviate pain, restore health, and extend life for people around the world. The Mission is our ethical framework and inspirational goal guiding our day-to-day work. It reminds us that our efforts are transforming millions of lives each year.

To meet the needs of patients and healthcare professionals around the globe, we operate from more than 370 locations in approximately 160 countries.

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