- 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.
- 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
- 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
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Description
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:
Must Have:
Your Profile:
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