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8 days old

Associate Configuration Assurance Administrator

Medtronic
Boulder, CO 80305
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Associate Configuration Assurance Administrator

Location:

Boulder, Colorado, United States

Requisition #:

20000EJW

Post Date:

Sep 12, 2020


**Careers That ChangeLives**


As an Associate Configuration Assurance Administrator on the
Quality Systems team, you will be a focal point for the processing and initiation
of changes to documentation that is directly related to our products and to the
Quality Management System vital to our medical devices which are sent out
across the globe to benefit surgeons and their patients.


**MITG**


The Minimally Invasive Therapies Group strives to enable
earlier diagnosis, better treatment, faster complication-free recovery, and
enhanced patient outcomes through less invasive surgical solutions.


**SURGICAL INNOVATIONS** sets the standard for Minimally
Invasive Surgery (MIS) by creating innovative surgical products and services
that focus on obesity and diseases and conditions of the gastrointestinal
tract, lung, abdominal wall, pelvic region, and the head and neck.


**A Day in the Life**


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.
Reviews and analyzes 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.


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


+ Maintain functional controlof product Master Data, document change control and Quality Systemrecords.

+ Analyze and coordinateproposed changes of product design and quality system processes todetermine effect on overall product and system, coordinating with changeowners, providing feedback.

+ Review and analyzeengineering change data and coordinate changes with engineering, quality,support, manufacturing, and engineering data control activities.

+ Ensure that customerrequirements are implemented, and reviews change accounting activity toensure compliance with configuration management policies.


**Must Have: MinimumRequirements**


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


+ Bachelors Degree with 0+ years of workexperience in Quality and/or experience in a regulated industry


**Nice to Have (PreferredQualifications)**


+ Background in hands-on use of technical documentation includingproduct design, manufacturing process, and quality systems.

+ Requires knowledge of technical or operational practices within assigneddiscipline.

+ Excellent communication skills- oral andwritten. Reading and writing accuracy is needed in establishing and maintainingorder in handling records.

+ 1+ years of configuration management or documentcontrol experience

+ Ability to understand and provide feedbackrelated to product design, manufacturingprocesses and the Quality Management System

+ Familiar with ISO 13485 quality systems

+ Agile PLM system for processing change orders.

+ Working knowledge of Microsoft Office tools,desktop publishing software experience (Microsoft Office Suite, Adobe Acrobat)

+ Familiar with modern ERP systems, PLM systemsand manufacturing documentation (i.e. BOMs, item masters, DHF, DMR, etc.)

+ Office Skills: telephones, word processing, dataentry, spreadsheet (PC), and database systems

+ Strong interpersonal communication skills

+ Able to work independently and within a team

+ Energized and self-actuated

+ Positive outlook


**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 above statements are intended to describe the general
nature and level of work being performed by employees assigned to this
position, but they are not an exhaustive list of all the required
responsibilities and skills of this position.


The physical demands described within the Day in the Life
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.


**EEO**


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.


This employer participates in the federal E-Verify program
to confirm the identity and employment authorization of all newly hired employees.
For further information about the E-Verify program, please click here: http at http://www.uscis.gov/e-verify/employees :// at http://www.uscis.gov/e-verify/employees www.uscis.gov/e-verify/employees
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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Posted: 2020-09-15 Expires: 2020-10-23
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Associate Configuration Assurance Administrator

Medtronic
Boulder, CO 80305

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