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Configuration Assurance Specialist

Medtronic


Location:
Fridley, MN 55432
Date:
27-11-2020
2020-11-272021-02-05
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Job Details

Configuration Assurance Specialist

Location:

Fridley, Minnesota, United States

Requisition #:

20000KBG

Post Date:

Nov 25, 2020


**Careers That Change Lives**


In this exciting role as a **Configuration Assurance Specialist** theprimary responsibility of this job is to plan and manage the configuration of documentation associated with Product Development throughout the product life cycle. Configuration Admins assists in and coordinates the creation, approval, and release of engineering documents within the current Product Lifecycle Management (PLM) system. Drives the timely release and change of product documentation according to project schedules through the interaction with documentation authors and approvers (from many levels of the organization). Communicates status of documentation and its configuration to engineers and project managers. Analyzes situations within defined, standard business procedures and practices for finding readily obtainable configuration management solutions to problems of moderate scope


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.


+ Analyzes proposed changes of product design to determine effect on overall product and system.

+ Coordinates modification records for management control.

+ Establishes change orders and prepares for change authorization and documentation by company and subcontractor.

+ Prepares reports of change effect on overall product.

+ Reviews and analyzes released engineering change data and coordinates changes with engineering, quality, support, manufacturing, and engineering data control activities.

+ Ensures that customer requirements are implemented and reviews change accounting activity to ensure compliance with configuration management policies.

+ Participates on the Change Control Board as CM Administrator or Configuration Management.

+ Participates in and leads special projects as assigned.


**Must Have: Minimum Requirements**


+ Bachelor'sdegree with 2 years of work experience in Quality or regulated industry OR Advanced degree with 0years of work experience in Quality or regulated industry


**Nice to Have:Preferred Requirements**


+ Strong attention to detail and accuracy.

+ Working knowledge of Microsoft Office tools, including but not limited to Word, Excel, PowerPoint and Visio to support data entry, spreadsheet, ERP software and database systems.

+ Strong attention to detail and accuracy.

+ Familiarity with ISO 13485 and FDA QSR quality systems.

+ Familiarity with ERP systems (SAP), PLM (Enovia and Agile) systems and IT systems.

+ Familiarity with manufacturing documentation (i.e., BOMs, item masters, DHF, DMR, etc.).

+ Experience with data collection and metric development/review.

+ Strong interpersonal communication and organization skills.

+ High capacity to multi-task; energized and self-actuated.


**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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