ANALISTA DE CAMBIOS

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Tijuana, Baja California
In-Office
Mid level
Healthtech
The Role
The role involves processing change orders, coordinating with stakeholders, managing change approvals, preparing reports, and ensuring compliance with regulations.
Summary Generated by Built In

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

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.

SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects – from design to implementation - while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education.

DIFFERENTIATING FACTORS

Autonomy: Entry-level individual contributor on a project or work team.
Works with close supervision.

Organizational Impact: Delivers work of limited scope, typically smaller, less complex projects or related activities.

Innovation and Complexity: Identifies, defines and addresses problems that are not immediately evident but typically not difficult or complex.
Makes minor changes in systems and processes to solve problems.

Communication and Influence: Communicates primarily with internal contacts within immediate group.
Contacts others to gather, confirm and convey information.

Leadership and Talent Management: N / A – job at this level is focused on self-development.

Required Knowledge and Experience: 

• Bachelor's degree in Business Administration, Engineering, or similar.

• 3 years of experience in similar role.

• Advanced English proficiency.

• Experience with Engineering Manage Change  processes.

• Knowledge of 21 CFR 820 and ISO 13485.

• Knowledge of Agile and Windchill methodologies.

• Customer service skills.

• Business Process Control (BPCS).

• Advanced Excel skills.

• Lean Manufacturing and Six Sigma experience.

• Experience in Project Management.

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. 

Benefits & Compensation

Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create.  We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
 

About Medtronic

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people. 
We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.

Learn more about our business, mission, and our commitment to diversity here  
 

Top Skills

Advanced Excel
Agile
Change Control
Compliance
Document Management
Electronic Document Management Systems
Enterprise Resource Planning (Erp) Systems
Lean Manufacturing
Product Lifecycle Management
Six Sigma
Windchill
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The Company
HQ: Minneapolis, MN
80,303 Employees

What We Do

Medtronic is a global healthcare solutions company operating in approximately 160 countries. We are committed to improving lives through our medical technologies, services, and solutions.

Since our beginning, 60 years ago, our Mission has remained the same: to alleviate pain, restore health, and extend life for people around the world. The Mission is our ethical framework and inspirational goal guiding our day-to-day work. It reminds us that our efforts are transforming millions of lives each year.

To meet the needs of patients and healthcare professionals around the globe, we operate from more than 370 locations in approximately 160 countries.

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