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- Document Control Process:
- Work with the QARA Manager and the Senior QARA Engineer to remediate all documents within the electronic document management system.
- Catalogue external links within documents and establish a process for monitoring of external links.
- Supplier Process:
- Improve the supplier onboarding and supplier revaluation activities.
- Create new documents to support the supplier process.
- Establish controls for critical suppliers.
- Create supplier quality agreements.
- Translation Process:
- Work with the QARA Manager and external translation house to identify gaps in the translation process.
- Create new documents to support the translation process.
- Update the translation process to meet the requirements of Regulation (EU) 2017/745.
- Registration Process:
- Create a documentation pack for each region to support registration of medical devices within Europe, Canada, Australia and the rest of the world.
- Create a master list of active registrations where Xstrahl hold market authorisation.
- Create a procedure/work instruction on the registration process.
- Experience of working in a medical device industry as a quality/regulatory engineer.
- Working knowledge of ISO 13485, ISO 14971 and Regulation (EU) 2017/745.
- Experience working with an electronic document management system.
- Experience in document control and use of an electronic document management system.
