**Careers that Change Lives**
Our Global Quality Strategy is rooted in the Medtronic Mission and our Quality Policy. Being a 'trusted partner' means always putting patient safety first, upholding product quality, and maintaining the highest ethical standards in our business relationships and programs.
**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**
- Bachelor's degree required.
- Requires 5+ years of experience or an Advanced Degree with a minimum of 3+ years relevant experience.
- Working knowledge of Microsoft Office tools, desktop publishing software experience (Microsoft Office Suite, Adobe Acrobat).
- Familiar with modern ERP systems, PLM systems and manufacturing documentation (i.e. BOMs, item masters, DHF, DMR, etc.).
- Bilingual English - Spanish Communication and excellent written and verbal communication. (C1 or B2+).
**Nice to Have**
- Knowledge & Experience in regulated industries such as Medical Devices, including ISO 9000, ISO 13485 and ISO 14971 requirements.
- Analytical skills and decision-making.
- Self-driven, resourceful and results-oriented.
- Strong results orientation (driving to deadlines, process KPIs, project goals, etc.)
- Strong analytical, planning, Quality, regulation, and organizational skills.
- Knowledge of Six Sigma Methodology and Lean Manufacturing.
- Proficiency in Project Management.
- Able to work independently and within a team.
- Must be amenable to work on a night shift schedule.
**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)