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Principal Quality Systems Specialist


Albion, MI 49224
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Job Details

Principal Quality Systems Specialist


Rice Creek, Minnesota, United States

Requisition #:


Post Date:

Jan 27, 2021

**Careers That Change Lives**

In this exciting role as a **Principal** **Quality** **Systems Specialist** you will have responsibility forsupporting the governance, maintenance, and improvement of the site Quality Management System.

The **Restorative Therapies Group** develops life-restoring therapies and healthcare solutions that span the care continuum; integrating technologies and applying clinical and economic evidence to increase patient access, improve efficiency of procedures and deliver successful patient outcomes.

**Neuromodulation** delivers innovative therapies and solutions for neurological diseases, pain, and spasticity.

**A Day in the Life**

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

+ Provides oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines.

+ Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.

+ Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations.

+ Supports audit and inspection preparation, resolution of audit and inspection findings.

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

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

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

+ Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of companys mission globally.

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

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

+ Providesquality metrics input for Quality Management Review.

+ Travel requirement:Less than 10%

**To be considered for this role, please ensure the minimum requirements are evident on your resume.**

Bachelorsdegree with 7+ years of work experience in Quality or regulated industry OR Advanced degree with 5+years of work experience in Quality or regulated industry.

**Nice to Have**

+ Excellent communication and presentation skills

+ Ability to work well under pressure in a dynamic timeline-driven environment

+ Previous work experience working with non-conformances, and corrective and preventive action reports

+ Experience with quality tools and process improvement techniques such as Lean Sigma, Kepner-Tregoe

+ Demonstrated strength in the review and writing of technical documentation

+ Influence management skills; ability to work constructively across all functions of the organization

+ Pro-active, energetic, self-assured professional with high personal integrity and ability to develop good interpersonal relationships

+ Experience with ISO13485. EU MDR and FDA Requirements

+ Strong critical thinking and analytical skills

**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.

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)
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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