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Principal Quality Systems Specialist


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Job Details

Principal Quality Systems Specialist


Heerlen, Limburg, Netherlands

Requisition #:


Post Date:

Nov 24, 2020

**Careers that Change Lives**

At Medtronic, we strive without reserve for the greatest possible reliability and quality in our products and processes. Medtronic Quality EMEA has established several Quality Processes that cover medical device sales, order management, supplier management, storage and distribution, customer information and education, technical service and spine loaner processes and that apply to different geographic regions: Western Europe, Central Eastern Europe, Middle East Africa. The Quality Systems are certified according ISO 13485 and/or ISO 9001, where the Heerlen Quality Processes team acts as the central office and all other sales organizations act as satellite.

We are currently looking for a Quality Systems Specialist to maintain and improve our Quality System.

**A Day in the Life**

You contribute to, maintain and improve the applicable Quality System by establishing the Quality Processes and supporting the local quality representative and process owners with the implementation of these processes. Next to this you provide advice and act as SME on ISO standards, Regulatory, and Corporate quality requirements, you conduct internal audits, you support/review preventive and corrective actions and participate in specific projects.

We offer you a position that allows you to be active throughout different parts of the organization and take the lead in different QA processes. You represent the QA department and you are in direct contact with different Quality Country Representatives and corporate Quality if applicable. You are expected to work independently on your task and will be part of the Quality Team.

Your main tasks and responsibilities include:

Provide Quality Systems advice to process owners within the scope of the EMEA and Distribution QMS.

Act as SME on the applicable ISO standards, Regulatory, Corporate or other Quality Requirements

Act as a delegate in one or more QMS processes.

Develop and provide training on applicable quality related subjects.

Perform internal and supplier audits.

Analyze data to identify trends and opportunities for improvement on quality aspects.

Support improvement projects.

See opportunities for quality system and quality process improvements and work with task teams in achieving these.

Investigating root cause of quality issues and approving corrective/preventive actions to prevent reoccurrence.

Do you have what it takes:

Bachelor Degree in Health Sciences, Health Policy, Business or similar;

At least 1-3 years of relevant working experience in a quality role in a highly-regulated environment (preferably in medical technology/logistical operational environment, regulatory affairs);

Excellent command of the English both spoken and written;

Willingness to travel (intern) national.

To be successful in this role you recognize yourself as a:

Self-starter, and a decision maker;

You have a strong passion for quality and continuous improvement;

you show a hands-on and result oriented approach to the application of quality tools;

You are a distinct standout colleague, whos able to establish relationships with colleagues in other countries and departments;

Handling several tasks, priorities and projects at once poses no problem for you and you can work well in a high pace environment;

Your excellent communication and presentation skills enable you to energize your audience and inspire change.

**About Medtronic**

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Lets work together to address universal healthcare needs and improve patients lives. Help us shape the future.
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
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