Change Analyst I

Careers that Change Lives
A Day in the Life

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

• Processes change orders, ranging from simple-to-complex, for the creation and revision of product, process, and system designs.
• Reviews and analyzes change data provided by all functions and facilitates coordination of changes with applicable stakeholders, including engineering, quality, manufacturing, operations and regulatory.
• Manages the change order process and prepares for change approvals by stakeholders.
• Prepares change management status reports.
• Ensures customer requirements are implemented while maintaining compliance to applicable policies, procedures, regulations, and standards.
• Functional Skills:
  Change Control, Document Management, Compliance, Product Lifecycle Management, Electronic Document Management Systems, Enterprise Resource Planning (ERP) Systems.
• Additional Skills:
  Problem Solving, Detail Oriented, Cross-Functional Collaboration, Customer Service, Process Improvement, Communication.

Must Have:
Minimum Requirements

• Requires 0+ years of experience with a High School Diploma or equivalent.

Nice to Have

• Bachelors Degree in Administrative, Engineering or similar.
• 3 to 5 years of experience in a similar position.
• Advanced English.
• Experience in engineering Change process.
• Knowledge of 21CFR 820, ISO13485
• Knowledge of GDPS, Oracle Agile
• Knowledge of Microsoft Office (Excel, Power point, Word)

Goal:
Ensure that Change Control methods;
The configuration, documentation and procedures used are appropriate for the management of all changes, in order to ensure compliance with corporate and local guidelines to avoid having any impact related to the change order, documentation that may impact the process of production. Must ensure the alignment and continuous improvement of the Quality Management System at the local and corporate level.

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. Let’s 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)
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