DOCUMENTATION ENGINEER
Undisclosed
1.Manage document numbers, revisions, approvals and obsolete versions, including drawings and software versions. 2. To capture decisions as development happens - organise the evidence required for reg
1.Manage document numbers, revisions, approvals and obsolete versions, including drawings and software versions.
2. To capture decisions as development happens - organise the evidence required for regulatory review for ISO 13485 medical device quality management system )
3. To establish clear, organised technical documentation demonstrating conformity.
4. Understand drawings, components, electrical systems, sensors, alarms, software and how the machine operates.
5.Compile technical file sections and track missing evidence, including the General Safety and Performance Requirements checklist.