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Senior Quality Systems Specialist

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Senior Quality Systems Specialist


Maastricht, Limburg, Netherlands

Requisition #:


Post Date:

Dec 03, 2020

**Careersthat Change Lives**

At Medtronic
Bakken Research Center (BRC) we design and manufacture a variety of commercial,
clinical investigational and custom-made medical devices. In addition, we have
a Translations group localizing Medtronic product documentation and software in
the language of our customers. You will join the Quality department at BRC and will
report into the BRC Quality Manager.

Click **here** at to see an overview of the activities and products developed at our Medtronic
BRC facility.

**A day inthe Life**

+ You are in charge of the overall BRCQuality Management Systems suitability, adequacy and effectiveness.

+ You take the lead in the developmentand maintenance of quality programs, systems, processes and procedures toensure the QMS is compliant to ISO13485 and 21CFRPart820.

+ You provide expertise and guidance toBRC process owners in interpreting corporate policies and regulatoryrequirements to assure compliance.

+ You establish and monitor the annualBRC internal audit program and perform audits yourself.

+ You coordinate and take the lead in hostingexternal audits from internal customers and regulatory bodies.

+ You pro-actively identify, analyzeand resolve (potential) quality issues within the BRC QMS by taking appropriateactions (e.g. CAPA) to ensure compliance and continuous improvement.

+ You act as process owner for severalsupporting processes within the BRC QMS for example document control, internalaudit, etc.

+ You promote awareness of applicable QualityManagement System requirements throughout the BRC organization.

+ You provide quality metrics inputfor Quality Management Review.

We are
looking for an experienced customer focused team player that is very pro-active
and naturally taking ownership. You will be working under limited supervision.

Besides the
ability to independently manage multiple tasks you dispose of good
problem-solving skills with critical thinking/decision skills and a high
attention to detail and accuracy.

You are a
good communicator and fluent in English, both in writing and speaking, to be
able to act as professional liaison for various internal and external


+ Bacheloror masters degree;

+ Atleast 5 years of experience in a Quality/Regulatory function with a demonstratedfocus on Quality Management Systems based on the medical device industrystandard ISO13485;

+ DemonstratedMDSAP and in particular FDA Quality System Regulation (21CFR Part820) knowledgeand experience.

**Nice tohaves:**

+ Knowledgeof Medical Device Regulation (EU) 2017/745 is a strong advantage;

+ Knowledge of Canadian MedicalDevices Regulations (CMDR) is a strong advantage;

+ Lead auditor certification is a strong advantage.

**About Medtronic**

As a global leader in medical technology, services and
solutions, Medtronic improves the health and lives of millions of people each
year. We believe our deep clinical, therapeutic and economic expertise can help
address the complex challenges - such as rising costs, aging populations and
the burden of chronic disease - faced by families and healthcare systems today.
But no one can do it alone. Thats why were committed to partnering in new
ways and developing powerful solutions that deliver better patient outcomes.

Founded in 1949 as a medical repair company, we're now
among the world's largest medical technology, services and solutions companies,
employing more than 85,000 people worldwide, serving physicians, hospitals and
patients in over 155 countries. With our European Operations Center for
Distribution and Shared Services in Heerlen, the Bakken Research Center in
Maastricht, our manufacturing facility in Kerkrade, and the Medtronic Eindhoven
Design Center and Dutch sales office in Eindhoven, Medtronic Netherlands has more
than 1,500 employees.

Whatever your specialty or ambitions, you can make a
difference at Medtronic - both in the lives of others and your career. Join us
in our commitment to take healthcare Further, Together.

We are an equal opportunity employer and value
diversity at our company. We do not discriminate on the basis of race,
religion, color, national origin, gender, sexual orientation, age, marital
status, veteran status, or disability status.
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.


Posted: 2020-12-08 Expires: 2021-02-14
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