Configuration Assurance Specialist
Careers that Change Lives
We are a learning culture. An inventive and collaborative group. We are dedicated to making sure that every patient gets the best product — when they need it. We have strong ties to our local communities. Our vibrant employee communities respect and value individual experience and perspective as we aim to improve lives and the access to healthcare.
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 of 2 years of experience with a High School Diploma or equivalent or Advanced Degree with 0 years of experience.
- Open to Fresh Graduates with a Science or Engineering degree
Your Profile:
- Good knowledge of Quality Systems Management Documentation
- Solid understanding of compliance requirements (ISO 13485)
- Experience in Change Management is an advantage
- Good time management skills
- Can work with minimal supervision
- Detail oriented and an agile learner
- Experience dealing with internal stakeholders
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 manag er or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.
