• Reduce change control volume by ensuring manufacture change orders’ technical content correctness and complying with company’s regulation.

• Work closely with R&D and Manufacture engineers to understand the intent of the change orders (CAD drawings, BOM, schematics, GDP, design verification protocols, service bulletins, risk assessment) and assist in meeting company’s regulations.

• Review CAD drawing and design verification protocols to ensure that all necessary changes are made in CAD drawing and proper GDP are documented in design verification protocols.

• Bring up issues arises during evaluation of change orders process that causes confusion during calibration meetings to align document control team and quality engineers.

• Advising engineers to consider checking other parameters, if the CAPA resolution stated in the change order is causing other issues while addressing the evaluation report.

• Attend daily floor meeting with Manufacture engineers to take care of urgent change orders that affects the production lines (stock purge) to ensure the production lines run smoothly.

• Evaluated and approved change orders in Agile.