Medical Device Document Administrator
hace 2 días
Aligntech is a pioneering company that has revolutionized the orthodontic industry with its Invisalign system. We believe in the transformative power of a great smile, and our technology gives people the confidence to take on new challenges.
Salary Range$120,000 - $160,000 per year, depending on experience and qualifications.
Job DescriptionThe Administrator, Global Document Services plays a critical role in driving document change and record control processes across the organization. This global role reports directly to the Senior Manager, Global Quality Services and is responsible for executing the global document change management and control processes.
- Process document changes involving quality management system documents belonging to Align sites around the globe.
- Interphase with technical teams, projects or departments in a timely, accurate and efficient manner.
- Maintain documentation system to ensure full compliance with Medical Device Regulations.
To be successful in this role, you will need:
- From 2 to 6 years of medical device industry experience.
- A University Bachelor Degree or equivalent.
- Experience in managing document control processes as required by ISO13485, ISO14971 and FDA 21CFR part 820 aligned systems/processes.
- Comfortable engaging and communicating with other sites within the company around the globe.
We offer a competitive salary, benefits package, and opportunities for professional growth and development.
About the RoleThis role provides advice and user support across the global business on the use of the global document change management and control software. You will also develop, implement and maintain activities ensuring products and processes are designed with adherence to the Quality Management System.
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