- Advise managers and engineers employed by our company what documents are required to document their work.
- This document retention process is for the purpose of documenting compliance with the standards specified in an internal company written Design Control Process in order to document that each stage of the design, engineering, testing and manufacturing of company auto-injector pens and other medical devices meet our company’s internal process documentation requirements, which requirements are in place to document that these devices meet United States FDA and European medical device regulations.
- Compile and maintain the Design History File for each device designed, engineered, tested and manufactured by our company.
- The Design History File is comprised of documentation of each design and engineering decision made by company engineers and managers on the way to the final design of each separate company device, its testing / verification results and its manufacture.
- There is a separate Design History File for each device.
- Assemble and calculate estimates for the costs to manufacture auto-injectors and other devices engineered and manufactured by our company.
- Cost estimates include cost of materials used to manufacture the devices, the cost of injection molding machines, calculating the cost and manufacturing capacities of the machines, as well as the number of workers required to produce a given number of devices in a given time period (the cost of labor).
- A separate cost estimate is required for each device.
Requires 24 months of experience in the position offered or as records manager or project manager or project coordinator or program management specialist for engineering or device design projects with regulatory requirements for document retention; with duties including calculating estimates for the costs to manufacture products or execute the project or program.