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1+ months

Sr. Quality Systems Specialist

Mounds View, MN 55112
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Sr. Quality Systems Specialist


Mounds View, Minnesota, United States

Requisition #:


Post Date:

Nov 06, 2020

**Careers That Change Lives**

In this exciting role as a Sr. Quality Systems Specialist, you
will have responsibility for oversight, execution and maintenance of compliance
activities for the Cardiac Ablation Solutions Business.

**CARDIACABLATION SOLUTIONS** provides a broad suite of electrophysiology
solutions intended to disrupt and lead the market in cardiac mapping and
ablation technologies for arrhythmia management.

**A Day in the Life**

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

+ Provides oversight for the development andmaintenance of quality programs, systems, processes and procedures that ensurecompliance with policies and that the performance and quality of servicesconform to established internal and external standards and guidelines.

+ Provides expertise and guidance in interpretingpolicies, regulatory and/or governmental regulations, and internal regulationsto assure compliance.

+ Works directly with operating entities toprovide process analyses oversight on a continuing basis to enforcerequirements and meet regulations.

+ Leads audit and inspection preparation,resolution of audit and inspection findings and liaises with auditing groupsand inspectors through all stages of the audits.

+ Prepares reports and/or necessary documentation(ex Corrective and Preventative Actions) and provides to applicablestakeholders, both internal and external.

+ Co-ordinates legal requests in support ofgovernment investigations or litigations.

+ Ensures the quality assurance programs andpolicies are maintained and modified regularly.

+ May lead front or back room activitiesassociated with audit and inspection.

+ Collaborate and reviews QMS changes to ensurecompliance with internal and external requirements maintained.

+ Provides quality metrics input for QualityManagement Review

+ May assist in document and product changesreview consistent with requirements in the document control system.

+ Facilitates uniform standards worldwide andenables best practice sharing, thereby fostering the achievement of company'smission globally.

**Must Have: MinimumRequirements**

**Tobe considered for this role, please ensure the minimum requirements are evidenton your resume.**

Bachelors Degree with 4+ years of experience in Quality
and/or regulated industry OR Advanced Degree with 2+ years of experience in
Quality and/or regulated industry.

**Nice to Have**

+ FDA inspection or Notified Body audit experience

+ Experience managing CAPA

+ Strong understanding of the Quality SystemRegulation and / or ISO 13485


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.

**Physical Job Requirements**

The physical demands described within the Responsibilities section of this job
description are representative of those that must be met by an employee to
successfully perform the essential functions of this job. Reasonable
accommodations may be made to enable individuals with disabilities to perform
the essential functions. For Office Roles: While performing the duties of this
job, the employee is regularly required to be independently mobile. The
employee is also required to interact with a computer, and communicate with
peers and co-workers. Contact your manager or local HR to understand the Work
Conditions and Physical requirements that may be specific to each role.
(ADA-United States of America)

Some travel, less than 25%, may be required.
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: 2020-11-10 Expires: 2021-03-21
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Mounds View, MN 55112

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