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1+ months

Quality Systems Specialist

Louisville, CO 80027
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Quality Systems Specialist


Louisville, Colorado, United States

Requisition #:


Post Date:

Jun 04, 2021

**Careers That Change Lives**

In this exciting role as a **Quality Systems Specialist,** you will have responsibility for managing assigned projects and working with other stakeholders to achieve desired results within the quality systems.

**The Cranial and Spinal Technologies Organization** 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.

Within **CST** this role will support the **Enabling Technologies,** delivering an innovative portfolio that includes advanced imaging, navigation, robotics, customized implants, and pre-operative planning aided by artificial intelligence

**Navigation** segments that offer an integrated portfolio of devices and therapies for the treatment of neurological disorders and diseases, as well as surgical technologies designed to improve the precision and workflow of neuro procedures.

**A Day in the Life**

Responsibilities include the following and other duties may be assigned.

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

+ Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulatory compliance.

+ Creates and maintains metrics and reporting for promotional labeling process.

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

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

+ 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 proactive sharing, thereby fostering the achievement of companys mission globally.

**Must Have: Minimum Requirements**

Bachelorsdegree with 2+ years of work experience in Quality or regulated industry OR Advanced degree with 0+years of work experience in Quality or regulated industry.

**Nice to Have (Preferred Qualifications)**

+ Experience with CAPA: Schedules meetings, follow-ups on progress, provides coaching and guidance, performs CAPA Specialist reviews approvals for CAPA Owners (including Engineers, Specialists, Managers, etc.); leads CAPA Board; currently training another Sr. Quality Systems Specialist and delegating CAPA Specialist activities

+ **Additional exposure may include the following:**

+ AAMI The Quality System Regulation 21 CFR 820 and ANSI/AAMI/ISO 13485

+ Think Reliability Cause Mapping

+ Lean Sigma Trainings

**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.


Posted: 2022-03-08 Expires: 2022-06-06
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Quality Systems Specialist

Louisville, CO 80027

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